System for transmitting electrical current to a bodily tissue

ABSTRACT

In some embodiments, an apparatus includes a substantially rigid base and a flexible substrate. The substantially rigid base has a first protrusion and a second protrusion, and is configured to be coupled to an electronic device. The flexible substrate has a first surface and a second surface, and includes an electrical circuit configured to electronically couple the electronic device to at least one of an electrode a battery, or an antenna. The flexible substrate is coupled to the base such that a first portion of the second surface is in contact with the first protrusion. A second portion of the second surface is non-parallel to the first portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/630,329 filed Feb. 24, 2015, which is a continuation of InternationalPatent Application No. PCT/US2010/058525, filed Dec. 1, 2010, whichclaims priority to and is a continuation-in-part of U.S. patentapplication Ser. No. 12/628,273 filed Dec. 1, 2009, now U.S. Pat. No.8,738,137, which is a continuation-in-part of U.S. patent applicationSer. No. 12/197,849 filed Aug. 25, 2008, now U.S. Pat. No. 8,467,880,which claims priority to U.S. Provisional Application Ser. No.60/957,592 filed Aug. 23, 2007, each of which is entitled “System forTransmitting Electrical Current to a Bodily Tissue,” and each of whichis incorporated herein by reference in its entirety.

BACKGROUND

The invention relates generally to medical devices, and specifically toa device for transmitting an electrical stimulation to a bodily tissueof a patient.

Known electrical stimulation systems are used in various medicalprocedures. For example, some known electrical stimulation systems areused to stimulate a response from a bodily organ or tissue of a patient,such as, for example, the heart, a muscle group or the like. Some knownelectrical stimulation systems are used to treat acute and/or chronicpain. One known electrical stimulation system, for example, is atranscutaneous electrical nerve stimulation (TENS) unit that provides anelectrical stimulation to an electrode attached to the skin of thepatient. The TENS unit includes a battery that must be sufficientlylarge to provide enough energy for a desired treatment period, often aperiod of several months, of electrical stimulation before replacement.Such a battery, however, may be obtrusive and/or burdensome for apatient to wear, for example, when the patient is in a long-termtreatment program. The TENS unit is connected to the skin electrodes bywires extending from the unit to the electrodes. Exposure of such wiresto moisture or fluid, for example as occurs during bathing, swimming,and/or perspiration, may result in unintended current loss or transfer,or shorting of the battery. The presence of such wires can also becumbersome and/or aesthetically unappealing for the patient.Furthermore, the electrode can lose its electrical and/or mechanicalproperties within several days, so regular replacement of the electrodeis required.

Some known systems are configured for use with a shorter-life battery;however, the system must be designed with a housing that can be openedto remove a used battery and to insert a new battery. Such a design canresult in a bulky device that must be worn by the patient.

Some known systems necessitate several connections between an electrodepatch and a stimulator. For example, known systems can include three orfour connections between the patch and the stimulator. Each additionalconnection increases the risk that the battery and/or the electricalcircuit can be shorted, for example due to the connectors being exposedto moisture, as described above.

What is needed is a compact medical device having a smaller batteryconfigured to provide power for a greater duration or a duration similarto the length of time during which an electrode retains its electricaland/or mechanical properties on a body of a patient. A need also existsfor a compact medical device having a rechargeable battery configured tobe rechargeable over a greater period of time and that is removablycouplable to a disposable electrode base. A need also exists for acompact medical device that is configured to reduce the risk of a shortcircuit and/or leakage of an electrical current, such as by having areduced number of mechanical connections with an external stimulatorand/or by having water-resistant components. A need exists for a medicaldevice capable of conforming to the curvature of a bodily tissue andproviding structural integrity to support an electronic device. A needalso exists for a medical device having a simplified manufacturingand/or assembly process.

SUMMARY OF THE INVENTION

In some embodiments, an apparatus includes a substantially rigid baseand a flexible substrate. The substantially rigid base has a firstprotrusion and a second protrusion, and is configured to be coupled toan electronic device. The flexible substrate has a first surface and asecond surface, and includes an electrical circuit configured toelectronically couple the electronic device to at least one of anelectrode a battery, or an antenna. The flexible substrate is coupled tothe base such that a first portion of the second surface is in contactwith the first protrusion. A second portion of the second surface isnon-parallel to the first portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an apparatus according to anembodiment.

FIG. 2 is a top view of an apparatus according to an embodiment.

FIGS. 3A-3B are perspective views of a negative terminal and a positiveterminal, respectively, of a portion of the apparatus of FIG. 2.

FIG. 4 is a bottom view of the apparatus of FIG. 2.

FIG. 5 is a top view of the apparatus of FIG. 2 with a portion of theapparatus in a covering.

FIG. 6 is a top view of the apparatus of FIG. 5 coupled to an externalstimulator.

FIGS. 7-8 are side views of the apparatus of FIG. 2 coupled to anexternal stimulator and disposed on bodily tissue and delivering anelectrical current to the bodily tissue and to an implanted conductivelead, respectively.

FIGS. 9A-9C are side views of portions of apparatus according toembodiments.

FIGS. 10-14 are side views of an apparatus according to embodiments andan external stimulator.

FIGS. 15-18 are top views of an antenna of an apparatus according toembodiments.

FIG. 19 is a side view of an apparatus according to an embodiment and anexternal stimulator.

FIG. 20 is a perspective view of an apparatus according to anembodiment.

FIG. 21 is a perspective view of a portion of an apparatus according toan embodiment.

FIG. 22 is a perspective view of a portion of the apparatus of FIG. 21.

FIG. 23 is a perspective view of an external stimulator configured foruse with the apparatus of FIG. 21.

FIG. 24 is a perspective view of the apparatus of FIG. 21 and theexternal stimulator of FIG. 23.

FIG. 25 is a perspective and partially transparent view of an apparatusaccording to an embodiment.

FIG. 26 is a perspective view of the apparatus of FIG. 25 and anexternal stimulator.

FIG. 27 is a perspective view of an apparatus according to an embodimentand an external stimulator.

FIG. 28 is a perspective view of a portion of an apparatus according toan embodiment and an external stimulator.

FIG. 29 is a perspective view of an apparatus according to anembodiment.

FIG. 30 is a perspective view of an apparatus according to an embodimentand an external stimulator.

FIGS. 31-33 are perspective views of apparatus according to embodimentsand an external stimulator.

FIG. 34 is a side view of an apparatus according to an embodiment.

FIG. 35 is a top view of the apparatus of FIG. 34.

FIGS. 36 and 37 are top and bottom perspective views, respectively, of aportion of a stimulator assembly according to an embodiment.

FIG. 38 is a perspective view of the stimulator assembly of FIG. 36including a battery.

FIG. 39 is an exploded perspective view of a stimulator assemblyaccording to an embodiment.

FIG. 40 is a perspective view of a portion of the stimulator assemblyshown in FIG. 42.

FIG. 41 is a bottom view of the stimulator assembly of FIG. 39.

FIG. 42 is a top view of the stimulator assembly of FIG. 39 with aportion of the housing removed.

FIG. 43 is an exploded perspective view of a stimulator assemblyaccording to an embodiment.

FIG. 44 is an exploded perspective view of the stimulator assembly ofFIG. 43.

FIG. 45 is a top view of a portion of the stimulator assembly of FIG. 43in a first configuration.

FIGS. 46-47 are top and bottom views, respectively, of a portion of thestimulator assembly of FIG. 43 in a second configuration.

FIG. 48 is a flow chart of a method of assembling a portion of astimulator system according to an embodiment.

FIG. 49 is a top view of two experimental apparatus according toembodiments.

FIG. 50 is a cross-sectional view of an apparatus of FIG. 49 taken alongline X-X.

FIG. 51 is a front view of an apparatus of FIG. 49 partially immersed ina liquid.

FIG. 52 is a front, cross-sectional view of a portion of a housingaccording to an embodiment.

FIG. 53 is a perspective, cross-sectional view of a portion of astimulator assembly according to an embodiment.

FIGS. 54-55 are top views of a stimulator assembly according to anembodiment in a first configuration and a second configuration,respectively.

FIGS. 56-57 are schematic illustrations of a stimulator system accordingto an embodiment in a first coupled configuration and a second uncoupledconfiguration, respectively.

FIGS. 58A-58D are front views of stimulator systems according toembodiments disposed on bodily tissue.

FIGS. 59-60 are top views of a stimulator assembly and an electrodeassembly, respectively, of a stimulator system according to anembodiment.

FIG. 61 is a side view of the stimulator system of FIGS. 59-60 disposedon bodily tissue and delivering an electrical current to an implantedconductive lead.

DETAILED DESCRIPTION

Apparatus and methods for transmitting an electrical signal (e.g., acurrent or stimulation) from an electronic device (e.g., an externalstimulator) to a bodily tissue of a patient are described herein. Alsodescribed herein are methods for assembling a portion of a stimulatorassembly for use in transmitting the electrical signal from theelectronic device to the bodily tissue. In some embodiments, anapparatus is configured to be disposed on bodily tissue (e.g., skin) ofa patient. The apparatus is configured to receive an electrical inputfrom an external stimulator via a connector and to transmit theelectrical input as an electrical current to an electrode disposed on orproximate to the bodily tissue. In this manner, the apparatus transmitsthe electrical stimulation to the bodily tissue.

As used herein, bodily tissue can include any tissue of a patientsuitable for receiving and/or conveying an electrical stimulation.Bodily tissue can include, for example, nervous tissue, such as a nerve,the spinal cord, or another component of the peripheral or centralnervous system. In another example, bodily tissue can include muscletissue, such as, for example, skeletal muscle, smooth muscle, or cardiacmuscle. Specifically, bodily tissue can include a group of tissuesforming an organ, such as, for example, the skin, lungs, cochlea, heart,bladder, or kidney. In still another example, bodily tissue can includeconnective tissue, such as, for example, skin, bone or bone-like tissue.

The apparatus is configured to treat a variety of medical conditions,including acute and/or chronic pain, and/or to activate a motor point.For example, the apparatus can be configured to transmit an electricalcurrent that at least partially activates conduction and/or propagationof action potentials (nerve impulses) along the axons of a target nerveassociated with a target bodily tissue. In another example, theapparatus can be configured to transmit to the bodily tissue anelectrical current that at least partially blocks the conduction and/orpropagation of action potentials along the axons of the target nerveassociated with the target bodily tissue.

The apparatus can be configured for transcutaneous and/or percutaneousstimulation of the target bodily tissue. In a treatment or procedure fortranscutaneous stimulation, for example, the apparatus is configured totransmit an electrical stimulation through bodily tissue from a firstelectrode positioned on a first location of the patient's skin to asecond electrode positioned on a second location on the patient's skindifferent from the first location. The pathway of the electrical currentthrough the bodily tissue of the patient is a transcutaneous stimulationpathway. In a treatment or procedure for percutaneous stimulation, forexample, the apparatus is configured to transmit an electricalstimulation to bodily tissue via an electrical lead. The electrical leadhelps direct the electrical current to the target bodily tissue. In someprocedures, the electrical lead can be completely implanted within thebodily tissue. In other procedures, the electrical lead is partiallyimplanted within the bodily tissue such that a portion of the leadextends through the skin.

In some embodiments, the apparatus can be a portion of a system forstimulation of the target bodily tissue. For example, in someembodiments, the apparatus includes a substrate and a base, wherein theapparatus is configured for use with an electronic device to deliver anelectrical current to the target bodily tissue. In another example, theapparatus includes a housing configured to be disposed about a portionof a stimulator assembly that is configured to transmit an electricalcurrent to the target bodily tissue.

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a material” is intended to mean one or morematerials, or a combination thereof.

FIG. 1 is a schematic illustration of an apparatus 100 according to anembodiment. The apparatus 100 is configured to transmit an electricalcurrent from a stimulator (not shown) through a bodily tissue of apatient. In this manner, the apparatus 100 is configured to stimulate atarget bodily tissue. The apparatus 100 can be, for example, anelectrode-battery assembly.

The apparatus 100 is configured to be disposed on or proximate to apatient's body, for example, on the skin of the patient. The apparatus100 can be coupled to the skin of the patient with an adhesive, abandage, or the like, or any combination of the foregoing.

The apparatus 100 includes a substrate 102, a power source 120, aconnector 132, electrical circuitry 150, and an electrode assembly 140.The substrate 102 has a first surface 104 and a second surface 106different than the first surface 104. The substrate 102 is configured tobe disposed on or proximate to the body of the patient. When theapparatus 100 is disposed on the patient's body, the second surface 106of the apparatus faces the patient's tissue, e.g., the skin.

The power source 120 is configured to provide power to an externalstimulator (not shown) coupled to the apparatus 100. The power source120 can be any suitable energy supplying source. For example, in someembodiments, the power source 120 is a battery. In some embodiments, thepower source 120 is an ultracapacitor or a supercapacitor. The powersource 120 is coupled to the substrate 102. In the schematicillustration, the power source 120 has a positive terminal 122 and anegative terminal 124. Each of the positive terminal 122 and thenegative terminal 124 are coupled to the substrate 102.

The connector 132 is configured to electrically couple the externalstimulator to the power source 120 and/or the electrical circuitry 150.The connector 132 can be any suitable mechanism for electricallycoupling the external stimulator and the power source 120. For example,in some embodiments, the connector 132 is configured to provide both amechanical and an electrical connection between the apparatus 100 andthe external stimulator. Said another way, when the external stimulatoris mechanically coupled to the apparatus 100 via the connector 132, theexternal stimulator is also placed in electrical communication with thepower source 120. The connector 132 can be any suitable connector,including but not limited to, a snap-fit connector. In some embodiments,the connector 132 is a metal electrode. In some embodiments, theconnector 132 is configured to provide a wireless electrical connectionbetween the external stimulator and the power source 120. In someembodiments, for example, the connector is an antenna configured totransmit a signal to and/or receive a signal from the externalstimulator. In some embodiments, the connector is a conductive ink, awire, or the like.

The connector 132 is disposed proximate to the first surface 104 of thesubstrate 102. In some embodiments, for example, the connector isembedded in the first surface 104 of the substrate 102. In someembodiments, the connector 132 is disposed on top of the first surface104 of the substrate 102. For example, the connector 132 can be aconductive ink printed onto the first surface 104 substrate. In stillother embodiments, a portion of the connector 132 is embedded in thesubstrate and another portion of the connector extends from the firstsurface 104. As illustrated in FIG. 1, the connector 132 is electricallycoupled to at least one of the positive terminal 122 and the negativeterminal 124 of the power source 120.

The electrical circuitry 150 is coupled to the substrate 102. Theelectrical circuitry 150 is configured to electrically couple theconnector 132 to the at least one of the positive terminal 122 and thenegative terminal 124 of the power source 120. In some embodiments, forexample, the electrical circuitry 150 includes a wire configured toelectrically connect the connector to the power source 120. In someembodiments, a portion of the electrical circuitry 150 is a pathway ofconductive ink printed onto the substrate 102.

At least one of the connector 132 or the electrical circuitry 150 isconfigured to prevent a short circuit of the electrical circuitcontained therein. The electrical circuitry 150 can include a variety ofsuitable mechanisms configured to prevent shorting the electricalcircuit (including shorting of the power source 120). For example, insome embodiments, the electrical circuitry 150 includes a fuseconfigured to open the electrical circuit in the presence of a thresholdelectrical load. In some embodiments, the electrical circuitry 150includes a switch biased towards an open position such that theelectrical circuit is incomplete until the switch is moved to a closedposition. In some embodiments, the electrical circuitry 150 includes adiode configured to prevent flow of an electrical current in anundesired direction. In some embodiments, the connector 132 isconfigured as a wireless connector. For example, the connector 132 canbe an antenna or a coil configured to wirelessly transmit and/or receivean electrical current between the external stimulator and the powersource 120. In this manner, the connector 132 can be disposed below asurface of the apparatus 100 or otherwise covered such that theconnector 132 is isolated from sources of moisture.

The electrode assembly 140 is coupled to the second surface 106 of thesubstrate 102. The electrode assembly 140 includes at least oneelectrode 142. The electrode 142 is configured to contact bodily tissue.For example, in some embodiments, the apparatus 100 includes a gelelectrode 142 configured to adhere to the patient's skin. The electrode142 is configured to facilitate transmission of an electrical currentthrough the bodily tissue.

FIGS. 2-8 illustrate an apparatus 200 according to an embodiment. Theapparatus 200 is configured to be disposed on a tissue (e.g., the skin)of a patient. The apparatus 200 includes a substrate 202, a power source220, a connection assembly 230, electrical circuitry 250, and anelectrode assembly 240.

The substrate 202 of the apparatus 200 is a printed circuit board(“PCB”). The PCB 202 has a first surface 204 (see, e.g., FIG. 2) and asecond surface 206 (see, e.g., FIG. 4). In use, the second surface 206of the PCB 202 faces the body of the patient and the first surface 204faces away from the body of the patient. The PCB 202 is flexible suchthat the PCB can substantially conform to the contours of the portion ofthe patient's body on which the apparatus 200 is disposed. For example,the PCB 202 can be configured to be flexible such that the PCB conformsto the curvature of a patient's arm, leg, or back. In this manner, thePCB 202 is configured to facilitate positioning and placement of theapparatus 200 on the patient's body.

The power source 220 is configured to provide power to an externalstimulator S (see, e.g., FIG. 6) coupled to the apparatus 200. The powersource 220 is a battery coupled to the PCB 202. Specifically, thebattery 220 is coupled to the PCB 202 by electrically conductive tabs226, 228. As illustrated in FIGS. 2, 3A, and 3B, the battery has apositive terminal 222 and a negative terminal 224. A first electricallyconductive tab 226 is coupled to the positive terminal 222. A secondelectrically conductive tab 228 is coupled to the negative terminal 224.Each of the first and second electrically conductive tabs 226, 228 arecoupled to the PCB 202. The electrically conductive tabs 226, 228 can becoupled to the PCB by any suitable coupling mechanism. For example, eachelectrically conductive tab 226, 228 can be coupled to the PCB 202 by atleast one of a solder joint, a braze joint, a weld, an adhesive, amechanical coupler, or the like, or any combination of the foregoing.Each of the first and second electrically conductive tabs 226, 228provides an electrical connection between its respective positiveterminal 222 or negative terminal 224 of the battery 220 and theelectrical circuitry 250, as described in more detail herein.

The connection assembly 230 includes a first connector 232, a secondconnector 234, and a third connector 236. The connectors 232, 234, 236are disposed proximate to the first surface 204 of the PCB 202. Thefirst and second connectors 232, 234, in conjunction with the electricalcircuitry 250, are configured to electrically couple the battery 220 andthe external stimulator S. Specifically, the first connector 232 iselectrically coupled to the positive terminal 222 of the battery 220 viathe electrical circuitry 250, and the second connector 234 iselectrically coupled to the negative terminal 224 of the battery via theelectrical circuitry.

The electrical circuitry 250 is at least partially coupled to the PCB202. In some embodiments, at least a portion of the electrical circuitry250 is a conductive material printed onto the PCB 202. As illustrated inFIG. 2, the electrical circuitry 250 includes a first electrical pathway252, a second electrical pathway 254, and a third electrical pathway256. The first electrical pathway 252 extends from the first connector232 to the first electrically conductive tab 226, which is coupled tothe positive terminal 222 of the battery 220. The first electricalpathway 252 is electrically coupled to the first electrically conductivetab 226, such as by at least one of a solder, a weld, a braze joint, aconductive adhesive, a mechanical coupler, or the like, or anycombination of the foregoing. Thus, the electrical circuitry 250, viathe first electrical pathway 252, electrically couples the firstconnector 232 to the positive terminal 222 of the battery 220.

The second electrical pathway 254 extends from the second connector 234to the second electrically conductive tab 228, which is coupled to thenegative terminal 224 of the battery 220. The second electrical pathway254 is electrically coupled to the second electrically conductive tab,such as by at least one of a solder, weld, braze joint, a conductiveadhesive, a mechanical coupler, or the like, or any combination of theforegoing. Thus, the electrical circuitry 250, via the second electricalpathway 254, electrically couples the second connector 234 to thenegative terminal 224 of the battery 220. In this manner, when theexternal stimulator S is coupled to the apparatus 200 via the first andsecond connectors 232, 234, a power circuit is completed between thebattery 220 and the external stimulator. When the power circuit iscompleted, the battery 220 can provide power to the external stimulatorS, which the external stimulator can use to generate an electricalcurrent for stimulating bodily tissue, as described in more detailherein.

The connection assembly 230 is configured to prevent a short circuit ofthe electrical circuit. The connection assembly 230 includes ahydrophobic barrier 218 coupled to the substrate 202. As illustrated inFIG. 2, the hydrophobic barrier is a Y-shaped barrier configured toincrease impedance of the electrical current between the first connector232, second connector 234, and/or the third connector 236, for example,when a portion of the substrate is wetted. An experiment testing theimpedance of such a barrier is described below with reference to FIGS.20-22. In use, the apparatus 200 may be wetted or otherwise exposed to asource of moisture, for example water or perspiration, which can createa leakage path for the electrical current between the first connector232, the second connector 234, and/or the third connector 236 of theconnection assembly 230. Such a leakage path for the electrical currentcan interfere with delivery of the electrical current intended tostimulate the bodily tissue and/or can cause leakage and discharge ofthe battery 220. The hydrophobic barrier 218 increases the impedancebetween at least one of the connectors 232, 234, 236 and another of theconnectors 232, 234, 236 and/or the wet surface of the substrate 202.The hydrophobic barrier 218 can be constructed of any suitable material,including, but not limited to, plastic, rubber, glue, or anothersubstantially non-conductive material.

The electrical circuitry 250 is also configured to prevent a shortcircuit of the electrical circuit. Specifically, as illustrated in FIG.2, the electrical circuitry 250 includes a fuse 258 in the secondelectrical pathway 254. The fuse 258 is coupled to the PCB 202. Forexample, the fuse 258 can be at least partially embedded in the PCB 202.

The fuse 258 has a closed configuration and an open configuration. Whenthe fuse 258 is in its closed configuration, the electrical circuitry250 is configured to allow transfer of an electrical current through thecircuitry between the battery 220 and the electrically coupled externalstimulator S. In other words, the electrical circuit is closed orcomplete. When the fuse 258 is in an open configuration, a gap orinterruption exists in the second electrical pathway 254. In otherwords, the electrical circuit is open or incomplete. The transfer ofelectrical current through the electrical circuitry 250 between thebattery 220 and the external stimulator S is inhibited when the circuitis open. As such, the battery 220 is substantially inhibited fromproviding power to the external stimulator S when the fuse is in itsopen configuration.

The fuse 258 is configured to be in (or is moved to) its openconfiguration in the presence of a threshold electrical load. Forexample, the fuse 258 can be a metal wire or strip configured to meltunder an abnormally high electrical load. In another example, the fuse258 can be configured to break under a threshold electrical load. Forexample, during use on the body of a patient, the connectors 232, 234,236 of the connection assembly 230 can be exposed when the externalstimulator S is not mechanically coupled to the apparatus 200. Theexposed connectors 232, 234, 236 create a risk of shorting the battery220, for example by exposure to fluid or an electrical charge, which cancause heating and/or explosion of the battery. The fuse 258, however, isconfigured to open the electrical circuit in the presence of thethreshold electrical load to prevent such a short of the battery.

The electrical circuitry 250 also forms a portion of a stimulationcircuit. The stimulation circuit includes the third connector 236, aportion of the electrical circuitry 250, such as the third electricalpathway 256, and the electrode assembly 240. The stimulation circuit iscomplete when the external stimulator is coupled to the third connector236. The electrical circuitry 250 of the stimulation circuit isconfigured to receive an electrical current from the external stimulatorvia the third connector 236. The electrical circuitry 250 is configuredto transmit the electrical current to at least one of a first electrode242 and a second electrode 244. The electrical circuitry 250 is alsoconfigured to receive at least a portion of the electrical current fromat least one of the first electrode 242 and the second electrode 244.The electrical circuitry 250 transmits the received electrical currentto at least one of the external stimulator S or the battery 220.

The electrode assembly 240 of the apparatus 200 is coupled to the secondsurface 206 of the PCB 202, as illustrated in FIG. 4. The electrodeassembly 240 includes the first electrode 242 and the second electrode244. As illustrated in FIGS. 7-8, each of the first electrode 242 andthe second electrode 244 is configured to contact bodily tissue T and tofacilitate transmission of an electrical current E through the bodilytissue, for example through subcutaneous bodily tissue located belowand/or between the first electrode 242 and the second electrode 244. Thefirst electrode 242 is configured to facilitate transmission of theelectrical current E from the external stimulator S through the bodilytissue T. The first electrode 242 can facilitate transmission of theelectrical current E to an electrical lead L at least partiallyimplanted within the bodily tissue, as illustrated in FIG. 8. The secondelectrode 244 is configured to receive at least a portion of theelectrical current E. As illustrated in FIGS. 7-8, for example, thesecond electrode 244 can receive electrical current E that has passedthrough the bodily tissue T and/or through an electrical lead L at leastpartially implanted within the bodily tissue. The transmission ofcurrent to an implanted lead is described, for example, in U.S. patentapplication Ser. No. 11/337,824, which is incorporated herein byreference in its entirety.

The electrodes 242, 244 are configured to adhere to bodily tissue (e.g.,the skin) of the patient. Each electrode 242, 244 of the electrodeassembly 240 includes a gel on the tissue-facing surface of theelectrode. The gel can be any suitable known gel including, but notlimited to, wet gels, karaya-gum-based hydrogels, and/or syntheticcopolymer-based hydrogels. The first electrode 242 and second electrode244 can be, for example, a cathodic gel electrode and an anodic gelelectrode, respectively.

As illustrated in FIG. 5, the apparatus 200 can be at least partiallyenclosed by a material 212, such as a material configured to increasethe comfort of the patient utilizing the apparatus and/or protectcomponents of the apparatus from external elements. The material atleast partially encloses at least one of the first surface 204 of thePCB 202, the battery 220, and a portion of the electrical circuitry 250.The material 212 defines an opening 214 through which the connectionassembly 230 is accessible. In this manner, the external stimulator Scan be physically coupled to the apparatus 200 via the connectionassembly 230, as illustrated in FIG. 6. The material 212 can be anysuitable material including, for example, a foam, a water-proofmaterial, plastic, an insulative material, a non-conductive material, afilm, or the like, or any combination of the foregoing.

In use, a target bodily tissue is identified as the target forelectrical stimulation. The apparatus 200 is positioned proximate to theidentified target bodily tissue, such as on a surface of the patient'sskin proximate to a subcutaneous target bodily tissue. For example, theapparatus 200 can be positioned proximate to an arm, leg, back, or otherportion of the patient's body. The first and second electrodes 242, 244are adhered to the patient's skin in the desired position.

The external stimulator S is placed in electrical communication with thebattery 220 of the apparatus 200. The external stimulator S iselectrically coupled to the battery 220 by coupling the externalstimulator to the connectors 232, 234. The battery 220 provides power tothe external stimulator S. In response to receiving power from thebattery 220, the external stimulator S generates an electrical currentand transmits the electrical current to the apparatus 200 via at leastone connector 232, 234, 236. The electrical current is transmitted viathe electrical circuitry 250 to the first electrode 242. The firstelectrode 242 transmits at least a portion of the electrical current Ethrough the bodily tissue of the patient, as illustrated in FIG. 7. Insome embodiments, as illustrated in FIG. 8, a portion of the electricalcurrent E transmitted from the first electrode 242 through the bodilytissue is picked by a proximal end portion of an electrical conductor L(or lead) at least partially implanted within the bodily tissue, asillustrated in FIG. 8. The electrical conductor L is configured totransmit a portion of the electrical current E from its proximal endportion to a distal end portion of the electrical conductor L. Theelectrical current E is transmitted from the distal end portion of theelectrical conductor L through the bodily tissue T to the secondelectrode 244. At least a portion of the electrical current E isreceived by the second electrode 244. The electrical circuitry 250transmits the electrical current E to at least one of the battery 220 orthe external stimulator S to complete one cycle of electricalstimulation of the target bodily tissue. The cycle of electricalstimulation of the target bodily tissue is repeated as necessary. Theapparatus 200 is disposable and can be removed from the patient anddiscarded when it is no longer needed or suitable for treatment, suchas, for example, when a prescribed course of treatment is completed orwhen the battery is exhausted.

Although the substrate 202 has been illustrated and described as being aPCB, in other embodiments, the substrate can be constructed of adifferent material. For example, the substrate can be constructed ofsilicon, polyamide, or another suitable polymer, or any combination ofthe foregoing.

Furthermore, although at least a portion of the electrical circuitry 250and/or the connection assembly 230 has been illustrated and described asbeing a conductive ink printed on a surface of the substrate 202, inother embodiments, at least one of the electrical circuitry and theconnection assembly can be differently constructed. For example, theconnection assembly can include a connector that is a wire, an antenna,a metal electrode, or the like. In another example, at least a portionof electrical circuitry can include or be a wire or another electricallyconductive material.

Although the material 212 is illustrated as at least partially enclosingat least one of the first surface 204 of the PCB 202, the battery 220,and a portion of the electrical circuitry 250, in other embodiments, amaterial can be disposed over a different portion of the apparatus 200.For example, in some embodiments, the material can be an insulative filmdisposed over a portion of the electrical circuitry.

Although the apparatus 200 has been illustrated and described as beingadhered to the body of the patient via adhesive gel electrodes, in otherembodiments, an apparatus can be coupled to the patient with a tape, astrap, a band, a glue, or another adhesive, or any combination of theforegoing. Furthermore, an apparatus that includes a glue, anotheradhesive, or the like, to adhere to the patient can include the glue,other adhesive, or the like on all or a portion of the portion of theapparatus contacting the body of the patient.

Although the apparatus 200 has been illustrated and described as havinga connection assembly 230 including a Y-shaped hydrophobic barrier 218,in other embodiments, an apparatus can include a barrier having adifferent configuration. For example, as illustrated in FIG. 9A, in someembodiments, an apparatus 260 can include a barrier 268, 269 disposedabout at least a portion of at least one connector 264, 266. In anotherexample, in some embodiments, as illustrated in FIG. 9B, an apparatus270 can include a plurality of barriers 278, 279 positioned at least onopposing sides of at least one connector 274. In still another example,as illustrated in FIG. 9C, in some embodiments, an apparatus can includea non-Y-shaped barrier 288 positioned between at least a first connector284 and a second connector 286.

FIG. 10 is an illustration of an apparatus 300 according to anembodiment. The apparatus 300 is configured to transmit an electricalcurrent from an external stimulator S₂ to a target bodily tissue. Theapparatus includes a substrate 302, a power source 320, a connectionassembly 330 including three connectors 332, 334, 336, electricalcircuitry 350 including a fuse 358, and an electrode assembly 340.

The substrate 302 includes a first layer 308 having a first surface 304and a second layer 310 having a second surface 306 different than thefirst surface. As illustrated in FIG. 10, each of the power source 320,the connectors 332, 334, 336, and the electrical circuitry 350 is atleast partially embedded in the first layer 308 of the substrate 302.The first layer 308 of the substrate is formed of a first material. Thesecond layer 310 of the substrate is formed over a portion of theelectrode assembly 350. The second layer 310 of the substrate is formedof a second material different than the first material.

As illustrated in FIG. 10, the apparatus 300 includes a magnet 366coupled to the substrate 302. The magnet 366 is configured to move aswitch in the external stimulator from a first position in which theswitch is electrically coupled to a first output channel to a secondposition in which the switch is electrically coupled to a second outputchannel different than the first output channel. For example, asillustrated in FIG. 10, movement of the magnet 366 from its firstposition can move the switch from a first position in which the switchis coupled to a high output channel (indicated as ChH) to a secondposition in which the switch is coupled to a low output channel(indicated as ChL). In this manner, the magnet 366 can be used tocontrol an amount of electrical current output from the externalstimulator S₂ to the apparatus 300.

Although the apparatus 200, 300 have been illustrated and described asincluding at first electrode 242, 342 and a second electrode 244, 344disposed on a second surface 206, 306 of a substrate 202, 302 andconfigured to facilitate transmission of an electrical current from anexternal stimulator S, S₂ through the bodily tissue, in someembodiments, an apparatus is configured to deliver or transmit theelectrical current to the bodily tissue in a different manner. Forexample, as illustrated in FIG. 11, an apparatus 400 according to anembodiment is an electrode-battery assembly configured for percutaneousdelivery of an electrical current to target bodily tissue.

The electrode-battery assembly 400 includes a substrate 402, a battery420, a connection assembly 430, electrical circuitry 450, and anelectrode assembly 440. The substrate 402 has a first layer 408 and asecond layer 410. The battery 420, and electrical circuitry 450 are atleast partially embedded in the first layer 408 of the substrate. Theelectrical circuitry 450 includes a fuse 458 configured to open theelectrical circuit in the presence of a threshold electrical load, asdescribed above.

An external stimulator S₃ is electrically coupled to theelectrode-battery assembly 400 via the connection assembly 430. Theconnection assembly 430 includes a first connector 432, a secondconnector 434, a third connector 436, and a fourth connector 438. Theconnectors 432, 434, 436, 438 of the connection assembly 430 extend froma surface of the first layer 408 of the substrate 402.

The third connector 436 is configured to receive an electrical currentinput from the external stimulator S₃. The third connector 436 isconfigured to transmit the electrical current via a first electricalpathway 452 of the electrical circuitry 450 to the fourth connector 438.The fourth connector 438 is physically and electrically coupled to anelectrode 446 of the electrode assembly 440 via a second electricalpathway 454. For example, as illustrated in FIG. 11, the fourthconnector 438 is coupled to the second electrical pathway 454 includingan electrical conductor exterior to the substrate 402 and extending fromthe fourth connector 438 to the electrode 446 implanted within thebodily tissue T.

The electrode assembly 440 includes a first electrode 442, a secondelectrode 444, and a third electrode 446. The first electrode 442 andsecond electrode 444 are coupled to the second layer 410 of thesubstrate 402. The third electrode 446 is coupled to the substrate 402via the second electrical pathway 454 and is configured to be at leastpartially implanted within the bodily tissue T. At least the thirdelectrode 446 is configured to transmit an electrical current from theexternal stimulator S₃ to the bodily tissue T. In use, the externalstimulator S₃ transmits an electrical current to the third connector436. The electrical current is transmitted from the third connector 436via the first electrical pathway 452 to the fourth connector 438, andfrom the fourth connector via the second electrical pathway 454 to thethird electrode 446. The third electrode 446 transmits at least aportion of the electrical current E to the bodily tissue, as illustratedin FIG. 11. The second electrode 444 is configured to receive at least aportion of the electrical current from the bodily tissue.

The electrode-battery assembly 400 is configured to receive anelectrical current from the external stimulator S₃ via at least one of afirst output channel and a second output channel of the externalstimulator. For example, as illustrated in FIG. 11, the externalstimulator S₃ has a high output channel ChH and a low output channelChL. The electrode-battery assembly 400 is illustrated in FIG. 11 asbeing electrically coupled to the low output channel ChL of the externalstimulator S₃ via the third connector 436, however, in use, a patient orpractitioner operating the stimulator can selectively electricallycouple the electrode-battery assembly to the high output channel ChH viathe third connector.

The external stimulator S₃ can be wirelessly controlled by the operator.For example, the operator can wirelessly control the external stimulatorS₃ using a remote control R to communicate with the stimulator over aradio frequency. In this manner, the operator can wirelessly program theexternal stimulator S₃, power on and/or off the external stimulator S₃,and/or select the desired output channel (e.g., ChH and/or ChL). In someembodiments, for example, the remote control R can a dedicatedprogramming device for use specifically with the stimulation system. Inother embodiments, however, the remote control R can be a personaldigital assistant (PDA) or other hand-held computing device that isconfigured to communicate with the external stimulator S₃. Such a PDA orhand-held computing device can include, for example, a CentralProcessing Unit (CPU) and electronic memory, and can be generally usedfor storing and organizing information and for providing tools foreveryday tasks. In such embodiments, the system can include an adaptorand/or cradle (not shown) configured to be coupled to and/or receive thePDA. The adaptor and/or cradle can enable the PDA to communicate withthe external stimulator S₃ such that external stimulator S₃ can bewirelessly controlled by the operator, patient or other user. Althoughdescribed as including an adaptor and/or cradle, in other embodiments,the external stimulator S₃ can be wirelessly controlled using a PDAand/or hand-held computing device without the need for an adaptor and/orcradle.

Although the apparatus 400 is illustrated and described aspercutaneously transmitting the electrical current, in some embodiments,an apparatus is configured for both transcutaneous and percutaneoustransmission of the electrical current. For example, an apparatus can beconfigured to transcutaneously transmit the electrical current throughbodily tissue from a first electrode disposed on a surface of thepatient's skin and percutaneously transmit the electrical current via asecond electrode (e.g., similar to electrode 446 described above) atleast partially implanted in the bodily tissue. In some embodiments, thehigh output channel ChH of the external stimulator is configured fortranscutaneous stimulation and the low output channel ChL is configuredfor percutaneous stimulation of the target bodily tissue. Electricalcurrent from each of the first electrode and the second electrode can bereceived by a third electrode disposed on the skin of the patient,similar to electrode 444 described above.

Although the apparatus 200, 300, 400 described above have beenillustrated and described as including a fuse 258, 358, 458 configuredto open the electrical circuit, in other embodiments, an apparatus 500includes electrical circuitry differently configured to prevent a shortcircuit of the electrical circuit, as illustrated in FIG. 12. Theapparatus 500 is configured to transmit an electrical stimulation to abodily tissue and includes a substrate 502, an electrode assembly 540, apower source 520, and a connection assembly 530.

The substrate 502 has a first surface 504 and a second surface 506different than the first surface. The power source 520 is coupled to thesubstrate 502 and can be any suitable source of power described herein.The power source 520 has a positive terminal 522 and a negative terminal524. The power source 520 is configured to provide power to an externalstimulator S₄, for example, when the external stimulator is inelectrical communication with the power source.

The electrode assembly 540 is coupled to the second surface 506 of thesubstrate 502. The electrode assembly 540 is configured to facilitatetransmission of an electrical current from the external stimulator S₄through the bodily tissue. The electrode assembly includes a firstelectrode 542 and a second electrode 544 different than the firstelectrode.

The connection assembly 530 is coupled to the substrate 502 and includesup to two connectors configured to be in electrical communication withthe external stimulator S₄. Specifically, as illustrated in FIG. 12, theconnection assembly 530 includes a first connector 532 and a secondconnector 534. Each of the first connector 532 and a second connector534 is coupled to the first surface 504 of the substrate 502. The firstconnector 532 is configured to electrically couple the externalstimulator S₄ to the positive terminal 522 of the power source 520 andto the first electrode 542. The second connector 534 is configured toelectrically couple the external stimulator S₄ to the negative terminal524 of the power source 520 and to the second electrode 544.

The connection assembly 530 has a first configuration in which the twoconnectors 532, 534 are electrically coupled to the external stimulatorS₄ (as illustrated in FIG. 12) and a second configuration in which thetwo connectors are electrically isolated from the external stimulator(not shown). When the connection assembly 530 is in its firstconfiguration, the connection assembly completes a power circuit betweenthe power source 520 and the external stimulator S₄ and a stimulationcircuit between the external stimulator and the electrode assembly 540,as described in more detail herein.

The power circuit includes electrical circuitry 550, a diode 562, theconnection assembly 530, and the power source 520. As illustrated inFIG. 12, the electrical circuitry 550 includes a first electricalpathway 552 and a second electrical pathway 554, each coupled to thesubstrate 502. The first electrical pathway 552 electrically couples thefirst connector 532 to the positive terminal 522 of the power source520. The second electrical pathway 554 electrically couples the secondconnector 534 to the negative terminal 524 of the power source 520. Whenthe connection assembly 530 is in its second configuration, the powercircuit is open (or incomplete). When the connection assembly 530 is inits first configuration such that the first and second connectors 532,534, respectively, are electrically coupled to the external stimulatorS₄, the power circuit is closed (or complete) and the power source 520provides power to the external stimulator.

The diode 562 is coupled to the substrate 502 and is disposed within thefirst electrical pathway 552. The diode 562 is configured to allowelectrical current to flow in a first direction and to substantiallyinhibit flow of the electrical current in a second direction differentthan the first direction. As illustrated in FIG. 12, the diode 562 isconfigured to allow flow of the electrical current from the power sourcein a first direction towards the first electrode 542 via the firstelectrical pathway 552. The diode 562 is configured to substantiallyinhibit flow of the electrical current in a second direction oppositethe first direction, such as from the first connector 532 to the powersource 520 and/or to the second electrode 544 via the first electricalpathway 552. In this manner, the diode 562 is configured to prevent ashort circuit of the electrical circuit because the stimulatingelectrical current transmitted from the external stimulator S₄ to thefirst connector 532 is substantially inhibited from flowing to the powersource 520, which otherwise may cause the power source to overheat,explode, or otherwise become defective.

The stimulation circuit includes electrical circuitry 550, a capacitor564, the connection assembly 530, and the electrode assembly 540. Asillustrated in FIG. 12, the electrical circuitry 550 includes a thirdelectrical pathway 556 coupled to the substrate 502. The thirdelectrical pathway 556 electrically couples the first connector 532 tothe first electrode 542 of the electrode assembly 540. The secondelectrical pathway 554 electrically couples the second connector 534 tothe second electrode 544. As such, the negative terminal 524 of thepower source 520 is also coupled to the second electrode 544.

The capacitor 564 is coupled to the substrate 502 and is disposed in theelectrical circuitry 550, for example, in the third electrical pathway556 as illustrated in FIG. 12. The capacitor 564 is configured toseparate an alternating current from a direct current. The capacitor 564is configured to substantially inhibit flow of the direct current fromthe power source 520 to the first electrode 542. The capacitor 564 isconfigured to deliver at least one of the alternating current and thedirect current from the external stimulator to the first electrode.

When the connection assembly 530 is in its first configuration (and thepower circuit is closed, as described above), the stimulation circuit isalso closed and an electrical current can be transmitted from theexternal stimulator through the target bodily tissue via the apparatus500. Specifically, the electrical current is transmitted from theexternal stimulator S₄ to the first connector 532. The first connector532 transmits the electrical current towards the first electrode 542 viathe third electrical pathway 556. The capacitor 564 separates directcurrent from alternating current, and then transmits at least one of thedirect current or the alternating current to the first electrode 542.The first electrode 542 transmits the electrical current through thebodily tissue T. The second electrode 544 receives at least a portion ofthe electrical current from the bodily tissue T and transmits theelectrical current to the electrical circuitry 550 of the apparatus 500.

Although the diode 562 has been illustrated and described as beingconfigured to allow flow of the electrical current from the power source520 in a first direction towards the first electrode 542 and tosubstantially inhibit flow of the electrical current in a seconddirection opposite the first direction, such as from the first connector532 to the power source 520 and/or to the second electrode 544 via thefirst electrical pathway 552, in some embodiments, the diode 562 isconfigured to allow flow of the electrical current in the seconddirection and to substantially inhibit flow of the electrical current inthe first direction.

Although the apparatus 500 has been illustrated and described as beingelectrically coupled to the external stimulator via the two mechanicalconnectors 532, 534, in some embodiments, an apparatus is electricallycoupled to the external stimulator in a different manner. For example,as illustrated in FIG. 13, in some embodiments, an apparatus 600 iswirelessly electrically coupled to an external stimulator S₅.

The apparatus 600 includes a substrate 602 configured to be positionedon or proximate to the bodily tissue T. The substrate 602 has a firstsurface 604 and a second surface 606 different than the first surface.The second surface 606 of the substrate is configured to face the bodilytissue and the first surface 604 is configured to face away from thebodily tissue when the apparatus is positioned on or proximate to thebodily tissue. A power source 620 is coupled to the substrate 602. Asillustrated in FIG. 13, the power source 620 is at least partiallyembedded in the substrate 602.

The apparatus 600 includes a connection assembly 630 configured to be inelectrical communication with an external stimulator S₅. The connectionassembly 630 includes a first connector 632 and a second connector 634.Each of the first connector 632 and the second connector 634 is anantenna configured as a first coil 614 and a second coil 616,respectively, that is configured to be in wireless electricalcommunication with the external stimulator S₅. The first coil 614 andsecond coil 616 are each coupled to the first surface 604 of thesubstrate 602. Specifically, the coils 614, 616 are embedded in thesubstrate 602. In this manner, the coils 614, 616 are configured toprevent a short circuit of the electrical circuit, for example, bysubstantially preventing exposure of the coils to a fluid.

The connection assembly 630 has a first configuration in which the coils614, 616 are electrically coupled to the external stimulator S₅ and asecond configuration in which the coils are electrically isolated fromthe external stimulator. The connection assembly 630 is configured tocomplete a power circuit between the power source 620 and the externalstimulator S₅ and a stimulation circuit between the external stimulatorand an electrode assembly 640, as described in more detail herein.

As illustrated in FIG. 13, the power circuit includes the first coil614, the power source 620, an oscillator 638, and electrical circuitry650. The electrical circuitry 650 includes a switch 660 disposed in afirst electrical pathway 652. The switch 660 can be any suitable switchfor opening and closing a circuit. For example, the switch 660 can be areed switch including a pair of contacts on ferrous metal reeds in ahermetically sealed glass envelope (not shown). The switch 660 has anopen configuration (see, e.g., FIG. 13) and a closed configuration. Inits open configuration, the pair of contacts of the reeds is open (orseparate). Thus, the electrical circuit is open when the switch is inits open configuration. The switch 660 is movable to its closedconfiguration by the introduction of a magnetic field, such as byplacing a magnet M in the external stimulator S₅ proximate to theswitch. Specifically, the presence of the magnetic field causes the pairof contacts to close or otherwise come together. As such, the switch 660is configured to close the electrical circuit when the switch is movedto its closed configuration. The switch 660 is biased to its openconfiguration. In this manner, the electrical circuitry is configured toprevent a short circuit of the electrical circuit.

The power source 620 is configured to transmit an electrical current tothe electrical circuitry 650 when the connection assembly 630 is in itsfirst configuration and the switch 660 is in its closed configuration.The electrical circuitry 650 is configured to transmit the electricalcurrent to the oscillator 638. The oscillator 638 is configured todeliver at least one oscillation (of electrical current) to the firstcoil 614 to initiate wireless transmission of an electrical output fromthe first coil to the external stimulator Ss. The first coil 614 isconfigured to wirelessly transmit the electrical output to the externalstimulator S₅, such as to a coil C₁. The coil C₁ of the externalstimulator S₅ can transmit the electrical current to a source of powerP₁ disposed within the external stimulator. The source of power P₁ cantransmit the electrical current to a stimulation circuit and/or a radiofrequency circuit coupled to the external stimulator S₅. For example,the source of power P₁ can transmit the electrical current to a portionof the stimulation circuit P₂ disposed on the external stimulator S₅.

As illustrated in FIG. 13, the stimulation circuit includes the secondcoil 616, electrical circuitry 650, and an electrode assembly 640. Thesecond coil 616 is disposed proximate to the first surface 604 of thesubstrate 602. Specifically, the second coil 616 is embedded in thesubstrate 602 proximate the first surface 604. The second coil 616 isconfigured for wireless electrical communication between an electrode ofthe electrode assembly 640 and the external stimulator S₅. For example,the second coil 616 is configured to receive an electrical input from acoil C₂ of the external stimulator S₅ and to transmit at least a portionof the electrical input (or current) to the electrical circuitry 650.

The electrical circuitry 650 is configured to transmit the electricalcurrent to the electrode assembly, for example, via a second electricalpathway 654. The electrode assembly 640 is coupled to the second surface606 of the substrate 602 and includes a first electrode 642 and a secondelectrode 644 different than the first electrode. The first electrode642 is coupled to the second electrical pathway 654 of the electricalcircuitry 650. The first electrode 642 can receive an electrical currentfrom the electrical circuitry 650 via the second electrical pathway 654and can facilitate transmission of the electrical current through thebodily tissue. The second electrode 644 is configured to receive aportion of the electrical current from the bodily tissue. The secondelectrode 644 is configured to transmit the electrical current to theelectrical circuitry 650, such as to a third electrical pathway 656. Theelectrical circuitry 650 can transmit the electrical current to thesecond coil 616. The second coil 616 can wirelessly transmit anelectrical output to the external stimulator S₅.

Although the apparatus 600 is illustrated and described as being inwireless communication with the external stimulator S₅ via a connectionassembly 630 including the first and second coils 614, 616,respectively, in some embodiments, an apparatus is in wirelesscommunication with an external stimulator via a connection assemblyhaving a different configuration. For example, in some embodiments, anapparatus includes at least one antenna configured to wirelesslycommunicate with an external stimulator.

As illustrated in FIG. 14, an apparatus 700 includes a connectionassembly 730 having a plurality of connectors that includes a firstconnector 732, a second connector 734, and a third connector 736. Theconnection assembly 730 is disposed proximate to a first surface 704 ofa substrate 702. Each of the first connector 732, second connector 734,and third connector 736 is configured to be coupled to a counterpartconnector (not shown) on the stimulator S₆. The first connector 732 isconfigured to be in electrical communication with a battery 720 coupledto the substrate 702 via a first electrical pathway 752 of electricalcircuitry 750. The first electrical pathway 752 includes a first switch712. The second connector 734 is configured to be in electricalcommunication with the battery 720 via a second electrical pathway 754.The second connector 734 is also configured to be in electricalcommunication with a first electrode 744 of an electrode assembly 740coupled to the substrate 702 via the second electrical pathway 754. Theelectrode assembly 740 can be coupled, for example, to a second surface706 of the substrate 702. The second electrical pathway 754 includes asecond switch 714. The third connector 736 is configured to be inelectrical communication with a second electrode 742 of the electrodeassembly 740 via a third electrical pathway 756. The third electricalpathway 756 includes a third switch 716. Each switch 712, 714, 716 isconfigured to move from an open configuration to a closed configurationin the presence of a magnetic field. For example, as illustrated in FIG.14, each switch 712, 714, 716 is configured to move to its respectiveclosed configuration by a magnet M₂ coupled to the external stimulatorS₆. When the switches 712, 714, 716 are each in the closedconfiguration, and the external stimulator S₆ is in electricalcommunication with the connection assembly 730, the electrical circuitis complete (or closed).

When the electrical circuit is complete, the battery 720 is configuredto provide power to the external stimulator S₆. Power from the battery720 enables the external stimulator to generate an electrical output tobe received as an electrical input by the third connector 736. Thesecond electrode 742 is configured to receive the electrical currentfrom the third connector 736 via the third electrical pathway 756. Thesecond electrode 742 is configured to transmit the electrical currentthrough target bodily tissue T. The first electrode 744 is configured toreceive at least a portion of the electrical current from the bodilytissue T and to transmit the electrical current to the externalstimulator S₆ via the second electrical pathway 754.

Although the apparatus 600, 700 have been illustrated and described asincluding two antenna coils 614, 616 and three connectors 732, 734, 736,respectively, in other embodiments an apparatus can include any suitablecombination of connectors, e.g., wired and/or wireless, for electricalcommunication with an external stimulator.

In some embodiments, as illustrated in FIG. 15, an apparatus 760includes a planar dipole antenna 764 that is printed onto a substrate762, such as a PCB. The antenna 764 includes a first connector 766, afirst branch 767, a second connector 768, and a second branch 769. Thefirst connector 766 is configured to be in electrical communication withan external stimulator (not shown). The first branch 767 is configuredto electrically couple the first connector 766 to electrical circuitry(not shown) coupled to the substrate 762. The second connector 768 isconfigured to be in electrical communication with the externalstimulator. The second branch 769 is configured to electrically couplethe second connector 768 to the electrical circuitry.

In some embodiments, as illustrated in FIG. 16, an apparatus 770includes a planar folded dipole antenna coupled to a substrate 772. Theantenna 774 includes a first connector 776, a first branch 777, a secondconnector 778, and a second branch 779. The first connector 776 isconfigured to be in electrical communication with an external stimulator(not shown). The first branch 777 is configured to electrically couplethe first connector 776 to electrical circuitry (not shown) coupled tothe substrate 772. The second connector 778 is configured to be inelectrical communication with the external stimulator. The second branch779 is configured to electrically couple the second connector 778 to theelectrical circuitry.

In yet another example, in some embodiments, as illustrated in FIG. 17,an apparatus 780 includes a planar non-symmetrical dipole antenna 784,which may also be referred to as a monopole antenna, coupled to asubstrate 782. The antenna 784 includes a first connector 786 and abranch 787. The first connector 786 is configured to be in electricalcommunication with an external stimulator (not shown). The branch 787 isconfigured to electrically couple the first connector 786 and electricalcircuitry (not shown) coupled to the substrate 782. The branch 787 canbe coupled to a power source 785. The antenna 764 includes a secondconnector 788 configured to be in electrical communication with theexternal stimulator.

In still another example, in some embodiments, as illustrated in FIG.18, an apparatus 790 includes a planar spiral antenna 794 coupled to asubstrate 792, such as a PCB. The antenna 794 includes a first connector796, a second connector 798, and an electrical pathway 797. Each of thefirst connector 796 and the second connector 798 is configured to be inelectrical communication with an external stimulator (not shown). Theelectrical pathway 797 electrically couples the first connector 796 tothe second connector 798. The electrical pathway 797 is configured as aspiral at least partially printed on a first surface 793 of the PCB 792.In some embodiments, a return electrical pathway (not shown) can be atleast partially printed on an opposing surface (not shown) of the PCB792. In some embodiments, a return electrical pathway can be at leastpartially printed on an inner layer of a multi-layered PCB.

Although the apparatus 200, 300, 400, 500, 600, 700 have beenillustrated and described as including a power source (or battery) 220,320, 420, 520, 620, 720, respectively, coupled to a substrate 202, 302,402, 502, 602, 702, respectively, in some embodiments, an apparatusincludes a power source that is the substrate.

For example, as illustrated in FIG. 19, an apparatus 800 includes aflexible battery 820 having a first surface 804 and a second surface806. The flexible battery 820 is configured to provide power to anexternal stimulator S₇ coupled the flexible battery 820. The externalstimulator S₇ can be coupled to the flexible battery by any couplingmechanism described herein that puts the external stimulator inelectrical communication with the apparatus 800. For example, asillustrated in FIG. 19, the apparatus 800 includes a connection assembly830 coupled to the first surface of the flexible battery 820. Theconnection assembly 830 is configured to complete a power circuitbetween the flexible battery 820 and the external stimulator S₇ and astimulation circuit between the external stimulator an at least oneelectrode. The connection assembly 830 includes a first connector 832and a second connector 834. Each connector 832, 834 is configured toelectrically couple the flexible battery 820 to the external stimulatorS₇. The first connector 832 is configured to electrically couple theexternal stimulator S₇ to a first electrode 842 of an electrode assembly840 via electrical circuitry 850. The second connector 834 is configuredto electrically couple the external stimulator S₇ to a second electrode844 of the electrode assembly via the electrical circuitry 850. Theelectrode assembly 840 is coupled directly to the second surface 806 ofthe flexible battery 820. Each of the first electrode 842 and the secondelectrode 844 is configured to contact a bodily tissue.

In use, when the external stimulator S₇ is electrically coupled to theflexible battery 820, the flexible battery provides power to theexternal stimulator. The external stimulator S₇ transmits an electricaloutput to the first connector 832. The first connector 832 transmits theelectrical input as an electrical current to the first electrode 842 viaa first electrical pathway 852. The first electrode 842 transmits theelectrical current through the bodily tissue to stimulate at least aportion of the bodily tissue. The second electrode 844 receives aportion of the electrical current from the bodily tissue. The secondelectrode 844 transmits the electrical current to the second connector834 via a second electrical pathway 854. The second connector 834transmits an electrical output to the external stimulator S₇.

The flexible battery 820 can be biodegradable. In some embodiments, forexample, the flexible battery 820 can include a plurality of carbonnanotubes, cellulose disposed between at least a portion of a firstcarbon nanotube and a second carbon nanotube, an electrolyte, and/or ametal foil of lithium and ion.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Elements of each embodiment described herein may be combinedin any suitable manner with one or more elements of another embodimentdescribed herein. Where methods described above indicate certain eventsoccurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

For example, although apparatus 200 is illustrated and described asincluding a fuse 258, in some embodiments, an apparatus similar toapparatus 200 may include a switch similar to switch 660 in addition toor instead of a fuse.

Although an apparatus has been illustrated and described herein asincluding one switch or three switches, in other embodiments, anapparatus can include any suitable number of switches, such as two,four, or more switches.

Although a switch has been illustrated and described herein as being inan open configuration in the absence of a magnetic field and as being ina closed configuration in the presence of a magnetic field, in otherembodiments, the switch can be differently configured. For example, insome embodiments, a switch can be configured to be in a closedconfiguration in the absence of a magnetic field and an openconfiguration in the presence of a magnetic field.

In another example, although an apparatus has been illustrated anddescribed herein as having mechanical connectors for connection to theexternal stimulator, in other embodiments, such an apparatus can includea wireless connector.

In still another example, although the apparatus have been illustratedand described as including two electrodes, in other embodiments, anapparatus can include any suitable number of electrodes. For example, insome embodiments, an apparatus includes a first cathodic electrode and aplurality of anodic electrodes. The plurality of anodic electrodes caninclude two, three, four, or more electrodes. Each electrode of theplurality of anodic electrodes can be selectively positioned at adesired location on the body of the patient, such as at spaced locationsto help direct an electrical current from the cathodic electrode througha greater area of bodily tissue. In other embodiments, for example, anapparatus can include a first anodic electrode and a plurality ofcathodic electrodes. The plurality of cathodic electrodes can transmit aplurality of electrical currents through the bodily tissue to the anodicelectrode. In still other embodiments, an apparatus can include aplurality of cathodic electrodes and a plurality of cathodic electrodes.

Although the apparatus have been illustrated and described as includinga substrate having a length and a width greater than a length of a firstdiameter of the power source and a width of a second diameter of thepower source, in other embodiments, an apparatus includes a substratehaving a different configuration. For example, as illustrated in FIG.20, an apparatus 301 can include a substrate 303 that has a firstportion 305 having a width W₁ equal to or greater than a diameter D ofthe power source 321 and a second portion 307 having a width W₂ lessthan the width W₁ of the first portion 305 of the substrate 303.

In yet another example, although the connectors 232, 234, 236 ofapparatus 200 have been illustrated and described as having a verticalorientation, in other embodiments, an apparatus can include at least oneconnector having a different orientation. For example, as illustrated inFIGS. 21-24, an apparatus 900 includes a substrate 902, a power source920, a connection assembly 930, electronic circuitry 950, an electrodeassembly 940, and a coupling mechanism 912 (not shown in FIGS. 21 and 22for clarity of illustration purposes).

The connection assembly 930 includes connectors 932, 934, 936, 938. Eachof the connectors 932, 934, 936, and 938 has a horizontal orientation.In other words, each of the connectors 932, 934, 936, and 938 has anorientation that is substantially parallel to a portion of the substrate902. In this manner, the external stimulator S₈ is moved laterally toengage and/or disengage with the connectors 932, 934, 936, 938 of theapparatus 900.

The connectors 932, 934, 936, 938 are electrically coupled to anelectrical pathway 952, 954, 956, 958, respectively, of the electroniccircuitry 950. The connectors 932, 934, 936, 938 are configured toelectrically couple the electronic circuitry 950 to the externalstimulator S₈ by being coupled to a counterpart connector R₁, R₂, R₃,R₄, respectively, of the external stimulator S₈ (see, e.g., FIG. 23).

The coupling mechanism 912 is configured to couple the externalstimulator S₈ to the apparatus 900. As illustrated in FIG. 24, thecoupling mechanism 912 is configured to engage a portion of the externalstimulator S₈. For example, the external stimulator S₈ can define agroove or recess configured to receive a portion of the first member ofthe apparatus 900. Although the apparatus 900 is illustrated as havingthe connection assembly 930 coupled to an end of the external stimulatorS₈ and the coupling mechanism 912 engaged with an opposite end of theexternal stimulator S₈, in other embodiments, the connection assemblyand/or the coupling mechanism can engage a different portion of theexternal stimulator S₈.

Additionally, although apparatus 200 is shown and described herein asincluding a power source 220 that is coupled to the PCB 202 byelectrically conductive tabs 226, 228, in other embodiments, the powersource can be electrically coupled to the substrate in any suitablemanner. For example, as illustrated in FIGS. 21-22, a portion 903 of thesubstrate 902 can be folded or otherwise disposed about a portion of thepower source 920. As also illustrated in FIG. 22, a portion of theelectrical pathway 954 can be disposed on the portion 903 of thesubstrate 902 that is folded or otherwise disposed about the portion ofthe power source 920. When the portion 903 of the substrate 902 isfolded about the power source 920, the portion of the electrical pathway954 contacts the power source 920. In this manner, a terminal of thepower source 920 can be electrically coupled to the PCB 202 by theelectrical pathway 954.

In some embodiments, as illustrated in FIGS. 25 and 26, an apparatus 901includes a housing 913. The housing 913 is configured to at leastpartially enclose components (e.g., as shown dashed lines in FIG. 25) ofthe apparatus 901, such as, but not limited to, a power source,electronic circuitry, a substrate, or the like. The housing 913 definesa perimeter 915 and a recess 917 within the perimeter 915. The recess917 is configured to at least partially receive an external stimulatorS₉, as illustrated in FIG. 26. A coupling mechanism 909 (a portion ofwhich is shown in dashed lines in FIG. 25) is configured to removablycouple the external stimulator S₉ to the housing 913. The couplingmechanism 909 is coupled to the housing 913 and includes a protrusion911. The protrusion 911 is configured to engage the external stimulatorS₉ when the external stimulator S₉ is at least partially received in therecess 917. The protrusion 911 is configured to release the externalstimulator S₉ when the protrusion 911 is pushed, depressed, or otherwisemoved by the operator (e.g., a physician or the patient). In someembodiments, the protrusion 911 is configured to move the externalstimulator S₉ in a direction away from the recess 917 when theprotrusion 911 is pressed or moved by the operator.

Although the apparatus 900 is illustrated and described herein asincluding four horizontally oriented connectors 932, 934, 936, 938configured to be coupled to the external stimulator S₈, in otherembodiments, an apparatus 921, 931 can be configured to receive ahorizontal protrusion of a external stimulator S₁₀, S₁₁, respectively,as illustrated in FIGS. 27 and 28.

In another embodiment, as illustrated in FIG. 29, an apparatus 941includes a receiving portion 943 configured to receive a portion of anexternal stimulator S₁₂ (not shown) and a protrusion 945 configured toengage an outer surface of the external stimulator S₁₂. In still anotherembodiment, an apparatus 951 is configured to be coupled to an externalstimulator S₁₂ without such a protrusion, as illustrated in FIG. 30.

Although the apparatus 901 has been illustrated and described herein asincluding a housing 913 having a certain outer shape and/or profile, inother embodiments, an apparatus can have a different outer shape and/orprofile. For example, an apparatus can include a housing having an outershape and/or profile like that of apparatus 961, 971, and/or 981, asillustrated in FIGS. 31-33.

Although various embodiments for transmitting an electrical current orstimulation from an electronic device or stimulator to a bodily tissuehave been described herein, additional embodiments are contemplated. Forexample, FIGS. 34-35 show a portion 170 of a stimulation systemaccording to an embodiment. The stimulation system can be any of thestimulation systems shown and described herein, and is configured totransmit an electrical signal or stimulus from a detachable electronicdevice (not shown) to a bodily tissue of a patient. The portion 170 ofthe stimulation system can be, for example, a portion of anelectrode-battery assembly. In another example, the portion 170 of thestimulation system can be a portion of an electrode base assembly.

The portion 170 of the stimulation system includes a base 172 and asubstrate 180. The base 172 is substantially rigid. An object withsubstantial rigidity can be characterized as having resistance todeflection and/or deformation in the presence of an external force(e.g., a bending force). The rigidity of an object is an extensiveproperty of the object being described, and thus is dependent upon thematerial from which the object is formed and certain physicalcharacteristics of the object (e.g., shape and boundary conditions). Forexample, the rigidity of an object can be increased or decreased byconstructing the object from a material having a high modulus ofelasticity. The modulus of elasticity is an intensive property of theconstituent material and describes an object's tendency to elastically(i.e., non-permanently) deform in response to an applied force. Inanother example, the rigidity of the object can be increased ordecreased by changing the flexural modulus of a material of which theobject is constructed. Flexural modulus is used to describe the ratio ofthe applied stress on an object in flexure to the corresponding strainin the outermost portions of the object. The flexural modulus, ratherthan the modulus of elasticity, is used to characterize certainmaterials, for example plastics, that do not have material propertiesthat are substantially linear over a range of conditions. In someembodiments, the base 172 can be constructed from a material having aflexural modulus of at least 750,000 p.s.i.

The base 172 includes a first protrusion 174 and a second protrusion176. The base 172 is configured to be coupled to the electronic device(not shown in FIGS. 34 and 35). For example, the base 172 can receive atleast a portion of the electronic device within the region 175 betweenthe first protrusion 174 and the second protrusion 176. At least one ofthe first protrusion 174 and the second protrusion 176 can be configuredto engage the electronic device when the portion of the electronicdevice is received by the base 172 (e.g., in a similar manner asdescribed above with respect to protrusion 911 of apparatus 901). Theelectronic device can be any suitable device including, for example, astimulator, an external pulse generator, or other electronic deviceshown and described herein.

The substrate 180 is flexible and is coupled to the base 172. Similarlystated, the substrate 180 has a low resistance to deflection,deformation and/or displacement when exposed to an external force. Inthis manner, the substrate 180 can be coupled to the base 172 such thatthe substrate 180 substantially conforms to the shape of one or moreportions of the base 172 (e.g., the first protrusion 174). As describedherein, this arrangement allows the substrate 180 to be wrapped, woven,and/or otherwise positioned relative to the base 172 in a flexiblemanner.

The flexibility of the substrate 180 is an extensive property, and thusis dependent upon the properties of the material from which thesubstrate 180 is constructed as well as certain physical characteristicsof the substrate 180 (e.g., shape). For example, the flexibility of thesubstrate 180 can be increased by constructing the substrate 180 from amaterial having a low modulus of elasticity and/or a low flexuralmodulus. In some embodiments the substrate 180 can have a modulus ofelasticity and/or a flexural modulus of less than approximately 750,000p.s.i. In other embodiments the substrate 180 can have a modulus ofelasticity and/or a flexural modulus of less than approximately 400,000p.s.i.

The flexibility of the substrate 180 can also be increased or decreasedby changing the shape, cross-sectional area and/or thickness of thesubstrate 180. Although the substrate 180 is shown as beingsubstantially planar and having a substantially constant thickness, inother embodiments, the substrate 180 can have a non-uniform thicknessand/or can have an irregular cross-sectional shape (e.g., corrugationsor the like) to result in the desired flexibility. Additionally, toincrease the flexibility, the substrate 180 can be thin. In someembodiments, for example, the substrate 180 can have a thickness ofapproximately 50 to approximately 120 microns (approximately 0.002 toapproximately 0.005 inches) or less.

In some embodiments, the substrate 180 can be a polymer, such as apolyester film, a polyimide film, or the like. Such polymers can alsoinclude, for example, Mylar®, Kapton® or the like. In other embodiments,the substrate 180 can be a reinforced polymer that includes, forexample, a polymer reinforced with glass fibers, graphite fibers, or thelike. Such materials can provide the electrical properties (e.g.,resistivity and/or conductivity) and the mechanical properties (e.g.,toughness, tear resistance, or the like) desired.

The substrate 180 has a first surface 181 and a second surface 182. Asshown in FIGS. 34-35, the substrate 180 is coupled to the base 172 suchthat a first portion of the second surface 182 is in contact with thefirst protrusion 174. A second portion of the second surface 182 isnon-parallel to the first protrusion 174. Said another way, when thesubstrate 180 is coupled to the base 172, a portion of the substrate 180is wrapped and/or woven about the first protrusion 174. Similarlystated, when the substrate 180 is coupled to the base 172, a portion ofthe substrate 180 is non-planar. The flexibility of the substrate 180facilitates coupling of the substrate to the base 172 such that thesubstrate 180 is partially disposed about the first protrusion 174.

The substrate 180 includes an electrical circuit 185. The electricalcircuit 185 is configured to electronically couple the electronic deviceto at least one of an electrode, a battery, or an antenna (not shown inFIGS. 34-35). In this manner, for example, the electrode can receive anelectrical signal or stimulation from the electronic device via theelectrical circuit 185. Also in this manner, the battery can providepower to the electronic device via the electrical circuit 185, forexample, to provide sufficient power to the electronic device for theelectronic device to generate an electrical signal or stimulation. Inanother example, the electrical circuit 185 can include the antenna(e.g., an antenna similar to at least one of antennae 614, 616, 764,774, 784, 794), which can be in wireless electrical communication withthe electronic device. In some embodiments, at least one of theelectrode, battery, or antenna is coupled to or otherwise disposed onthe substrate 180.

FIGS. 36-38 show a portion of a stimulation system 370 according to anembodiment. The stimulation system can be configured for use with asystem to transmit an electrical signal from an electronic device (notshown) to a bodily tissue of a patient. The electronic device can be anysuitable electronic device for producing an electrical signal, includingany of the electronic devices shown and described herein.

The portion of the stimulation system 370 includes a substantially rigidbase 372 and a flexible substrate 380. The flexibility of the substrate380 facilitates conformance of the substrate 380 to portions of the base372 and/or to a curvature of a body of the patient. Because the base 372is substantially rigid, the base is configured to provide structuralsupport to the substrate 380 when the substrate 380 is coupled to thebase. The base 372 also has sufficient structural integrity to couplethe electronic device to the portion of the stimulation system 370and/or support the electronic device relative to the stimulation system.

The base 372 includes a first protrusion 374 and a second protrusion376. The first protrusion 374 and the second protrusion 376 of the base372 are each configured to maintain contact (e.g., electrical and/orphysical contact) between the electronic device and at least the portionthe stimulation system 370. For example, at least a portion of theelectronic device can be received between the first protrusion 374 andthe second protrusion 376 of the base 372. In some embodiments, forexample, the first protrusion 374 and the second protrusion 376 areconfigured to be positioned adjacent a first end portion and a secondend portion, respectively, of the electronic device when the electronicdevice is received between the first protrusion 374 and the secondprotrusion 376. In some embodiments, the first protrusion 374 and thesecond protrusion 376 collectively define an interference fit and/or a“snap fit” with the electronic device when the electronic device isreceived between the first protrusion 374 and the second protrusion 376.In this manner, the first protrusion 374 and/or the second protrusion376 limit the movement of the electronic device relative to the base 372when the electronic device is coupled to the base 372. In someembodiments, for example, the first protrusion 374 and/or the secondprotrusion 376 are configured to matingly engage (e.g., via a tab,recess, detent or the like) a portion of the electronic device. In someembodiments, the second protrusion 376 is engaged with an end of theelectronic device when the electronic device is coupled to the base 372(e.g., as shown and described herein with respect to protrusion 911 ofapparatus 901).

The base 372 defines a set of slots including a first slot 371, a secondslot 373, and a third slot 375, each being different than the others.Similarly stated, the base 372 defines a series of elongated openings371, 373, 375 that are distinct and/or non contiguous from each other.In other embodiments, however, the first slot 371, the second slot 373and/or the third slot 375 can be contiguous and/or can share at least aportion of a common boundary. The first slot 371, the second slot 373and the third slot 375 each receive a portion of the flexible substrate380 when the flexible substrate 380 is coupled to the base 372.Similarly stated, the flexible substrate 380 is woven within the firstslot 371, the second slot 373 and the third slot 375. More particularly,at least a first portion of the substrate 380 is disposed within thefirst slot 371 defined by the base, and at least a second portion of thesubstrate is disposed within the second slot 373 defined by the base, asillustrated in FIGS. 36-37.

The arrangement of the flexible substrate 380 within the first slot 371,the second slot 373 and the third slot 375 results in at least a portionof the flexible substrate 380 being wrapped about the first protrusion374 of the base 372. In some embodiments, disposal of the substrate 380within at least one of the slots 371, 373, 375 of the base 380 alsoserves to couple the substrate to the base 372. Moreover, thearrangement of the flexible substrate 380 within the first slot 371, thesecond slot 373 and the third slot 375 can be used to index and/orposition the substrate 380 relative to the first protrusion 374 in apredetermined position. In this manner, as described in more detailbelow, a portion of the electrical circuit 385 included within thesubstrate 380 can be placed in electrical and/or physical contact withthe electronic device.

The substrate 380 has a first surface 381 (e.g., an “upper surface”) anda second surface 382 (e.g., a “lower surface”). The substrate 380 iscoupled to the base 372 such that a first portion 383 of the secondsurface 382 of the substrate is in contact with the first protrusion 374of the base. When the substrate 380 is coupled to the base 372, a secondportion 384 of the second surface 382 of the substrate 380 isnon-parallel to the first portion 383 of the substrate, as illustratedin FIGS. 36-37. For example, in some embodiments, the first portion 383of the second surface 382 of the substrate 380 is substantiallyperpendicular to the second portion 384 of the second surface of thesubstrate 380 when the substrate 380 is coupled to the base 372.

The substrate 380 includes an electrical circuit 385. The electricalcircuit 385 can include, for example, any suitable electricalcomponents, via, conductors and/or the like interconnected to performthe functions described herein. More particularly, the electricalcircuit 385 includes electrical pathways 387, 386, 389. The electricalpathways can be, for example, conductive traces or metallic stripsdisposed on the flexible substrate 380. At least a portion of theelectrical circuit 385 is included on the first surface 381 of thesubstrate 380, and is configured to be in electrical communication withthe electronic device. For example, the portion of the electricalcircuit 385 on the first surface 381 can be complementary to (e.g., onthe opposite side of the substrate 380 from) the first portion 383 ofthe second surface 382 of the substrate 380, such that the portion ofthe electrical circuit 385 is at least partially disposed about thefirst protrusion 374 of the base 372. In this manner, for example, theportion of the electrical circuit 385 can be engaged with and/ordisposed proximate to an end of the electronic device when theelectronic device is coupled to the base 372. When the portion of theelectrical circuit 385 is engaged with and/or disposed proximate to anend of the electronic device, the electrical circuit 385 canelectrically communicate with the electronic device in any mannerdescribed herein, including via wired and/or wireless electricalcommunication.

The electrical circuit 385 is configured to electronically couple theelectronic device to at least one of an electrode, a battery, or anantenna. For example, as illustrated in FIG. 38, the electrical circuit385 can electronically couple the electronic device to a battery 394 viaat least one electrical pathway 387, 389 when the electronic device iscoupled to the base 372. More particularly, the battery 394 can becoupled to the first surface 381 of the flexible substrate 380 such thata portion of the electrical pathway 387 is electrically coupled to afirst terminal of the battery 394 and a portion of the electricalpathway 389 is coupled to a second terminal of the battery 394. Inparticular, the portion of the electrical pathway 389 is coupled to asecond terminal of the battery 394 by a connector and/or tab similar tothe conductive tabs 226, 228 shown and described above. Correspondingterminals of the electronic device (not shown in FIGS. 36-38) are alsoplaced in electrical communication with the electrical pathways 387, 389when the electronic device is coupled to the base 372 to complete theelectronic connection. In this manner, the battery 394 can provide powerto the electronic device via the electrical circuit 385 when theelectronic device is coupled to the base 372.

The battery 394 can be any suitable battery, such as, for example, aZinc-Air battery, a Silver-Oxide battery, a Lithium coin battery, aLithium ion rechargeable battery and/or the like. In embodiments thatinclude a rechargeable battery, the electronic device can be arecharging unit, and can be configured to supply power to the battery394 via the electrical circuit 385 when the electronic device is coupledto the base 372. Although stimulation system 370 is illustrated anddescribed as including a battery 394, in other embodiments, thestimulation system can include a different source of power, includingany source of power shown and described herein.

As illustrated in FIG. 37, the electrical circuit 385 can electronicallycouple the electronic device to an electrode 392 via an electricalpathway 386. In use, an electrical signal or stimulus can be transmittedfrom the electronic device through the electrical pathway 386 to theelectrode 392. In addition to the electrode 392, the electrical signalor stimulus can be transmitted via the electrical circuit 385 to atleast one hydrogel electrode 397, 399 coupled to the second surface 382of the substrate 380. More particularly, the electrical circuit 385 canelectronically couple the electronic device to the hydrogel electrodes397, 399 (illustrated in FIG. 38), such as via electrical pathway 388 orvia electrical pathway 386 and electrode 392, respectively.

At least a portion of the substrate 380 also includes a conductiveregion 398 and a plurality of non-conductive regions 396. In particular,as illustrated in FIG. 37, the second surface 382 of the substrate 380can include at least one of the conductive region 398 and the pluralityof non-conductive regions 396. For example, at least one of theconductive region 398 and/or the plurality of non-conductive regions 396can be disposed on the second surface 382 of the substrate 380. Asdescribed herein, this arrangement facilitates both the mechanical andelectrical coupling of the hydrogel electrode 397 and/or the hydrogelelectrode 399 to the substrate 380. In particular, as shown in FIGS. 37and 38, the conductive and non-conductive regions 398, 396 areconfigured to contact the hydrogel electrode 397. The conductive region398 is in electrical communication with the electrical circuit 385,e.g., via the electrical pathway 388. As such, the conductive region 398is configured to transmit an electrical signal or stimulus from theelectrical circuit 385 to the hydrogel electrode 397. In otherembodiments, the substrate 380 can include more than one conductiveregion 398 and plurality of non-conductive regions. For example, in someembodiments, the substrate can include a second conductive region (notshown) and a second plurality of non-conductive regions (not shown)configured to place the hydrogel electrode 399 in electricalcommunication with the electrical circuit 385, e.g., via the electricalpathway 386.

In some embodiments, the plurality of non-conductive regions 396 isincluded within and/or adjacent the conductive region 398. For example,the plurality of non-conductive regions 396 can be disposed on a surfaceof the conductive region 398. Each non-conductive region of theplurality of non-conductive regions 396 is discrete from the othernon-conductive regions of the plurality. At least one non-conductiveregion of the plurality of non-conductive regions 396 extends beyond (oraway from) a surface of the conductive region 398. Said another way, atleast one non-conductive region of the plurality of non-conductiveregions 396 is substantially non-planar with the conductive region 398.Said yet another way, at least one non-conductive region of theplurality of non-conductive regions 396 forms a surface textured area onthe conductive region 398 of the substrate 380. In this manner, when thehydrogel electrode 397 is in contact with the substrate 380, theplurality of non-conductive regions 396 and the conductive region 398collectively reduce the likelihood that the hydrogel electrode 397 willpeel or otherwise move away from the conductive region 398 of thesubstrate 380 (e.g., in the presence of shearing forces). As such, theplurality of non-conductive regions 396 is configured to facilitatecoupling and/or the mechanical connection, between the hydrogelelectrode 397 and the substrate 380. Said another way, the plurality ofnon-conductive regions 396 is configured to facilitate retention of thehydrogel electrode 397 with respect to the conductive region 398 of thesubstrate 380.

Further, because each discrete non-conductive region of the plurality396 is surrounded on its perimeter by the conductive region 398, anelectrical current can be evenly distributed through the hydrogelelectrode 397. Even distribution of the electrical current from theconductive region 398 of the substrate 380 through the hydrogelelectrode 397 can reduce and/or prevent electrical “hotspots” (i.e.,areas of concentrated electrical stimulation that can cause skinirritation and/or uncomfortable sensations to a patient).

The plurality of non-conductive regions 396 can be formed in anysuitable manner. For example, in some embodiments, at least onenon-conductive region of the plurality of non-conductive regions 396 isa solder mask. Use of a solder mask to form the plurality ofnon-conductive regions 396 on the conductive region 398 permits theplurality of non-conductive regions to be formed in any suitable desiredpattern on the conductive region 398. Any known suitable method and/ormaterial for producing the solder mask may be used. In another example,at least one non-conductive region is formed by a coating applied to thesurface of the conductive region 398.

Although the plurality of non-conductive regions 396 have been describedherein as being disposed on the conductive region 398 of the substrate380, in other embodiments, the plurality of non-conductive regions canbe included within and/or adjacent the conductive region in any suitablemanner. For example, at least one non-conductive region of the pluralityof non-conductive regions can be a cavity or other depressed portionformed in a surface of the conductive region of the substrate. Thecavity can be configured to receive a portion of the hydrogel electrode,thereby facilitating retention of the hydrogel electrode with respect tothe conductive region of the substrate. In some embodiments, the cavityis formed by etching one or more discrete portions of the conductiveregion. For example, in some embodiments, the conductive region includesa metal layer disposed on or otherwise coupled to the substrate and theplurality of non-conductive regions is formed by etching away discreteportions of the metal layer. In another example, at least onenon-conductive region of the plurality of non-conductive regions can bean aperture or other opening defined by the conductive region of thesubstrate. Such an aperture or other opening can be formed, for example,by punching the aperture or other opening in the conductive region ofthe substrate with a mechanical punch. The aperture can be configured toreceive a portion of the hydrogel electrode, thereby facilitatingretention of the hydrogel electrode with respect to the conductiveregion of the substrate. Although various manners for forming thenon-conductive regions have been described herein, the plurality ofnon-conductive regions can be formed in any suitable manner, includingany combination of the foregoing manners.

Each non-conductive region of the plurality of non-conductive regions396 can be of any suitable size and/or shape. For example, asillustrated in FIG. 37, at least one non-conductive region of theplurality of non-conductive regions 396 can be in the shape of square(or a three-dimensional cube). The at least one non-conductive regioncan be, for example, a 1 mm×1 mm square. In other embodiments, at leastone non-conductive region can be rectangular, triangular, oval,circular, or any other suitable shape. Additionally, the at least onenon-conductive region can have dimensions of a size different than 1mm×1 mm, such as a length, width, and/or cross-sectional diameter ofgreater than approximately 1 mm (e.g., approximately 2 mm toapproximately 4 mm) or less than approximately 1 mm (e.g., approximately0.3 mm to approximately 0.8 mm).

Although the portion of the substrate 380 including the conductiveregion 398 and the plurality of non-conductive regions 396 isillustrated and described as having a substantially circular shape, inother embodiments, the portion of the substrate can have any suitableshape. For example, in some embodiments, the portion of the substratecan be oval, rectangular, square, or another suitable shape.

Additionally, the portion of the substrate 380 including the conductiveregion 398 and plurality of non-conductive regions 396 can be of anysuitable size. For example, the portion of the substrate 380 can have adiameter of approximately 30 mm. In another embodiments, the portion ofthe substrate can have a diameter of less than 30 mm (e.g., a diameterwithin the range of approximately 10 mm to approximately 30 mm). Instill other embodiments, the portion of the substrate can have adiameter of greater than 30 mm (e.g., a diameter within the range ofapproximately 30 mm to approximately 60 mm).

The substrate 380 can be constructed of any suitable material. In someembodiments, for example, the substrate 380 is a flexible PCB. Inanother example, the substrate can be constructed of a differentmaterial, including silicon, polyamide, or another suitable polymer, orany combination of the foregoing.

Although stimulation system 370 is illustrated and described as havingone portion of the substrate 380 including the conductive region 398 andthe plurality of non-conductive regions 396 associated with the hydrogelelectrode 397, in other embodiments, an apparatus can include more thanone conductive region and more than one plurality of non-conductiveregions. For example, in other embodiments, the substrate can include anumber of conductive region and a number of non-conductive regionscorresponding to, or equivalent to, the number of hydrogel electrodes tobe utilized with the apparatus (e.g., two, three, or more).

FIGS. 39-42 show portions of a stimulator assembly 495 according to anembodiment. In particular, the stimulator assembly 495 includes abattery 494, an electrode 497, a stimulus generator 490, a substrate480, a base 472 and a housing 465. The stimulator assembly 495 can beused to transmit an electrical current from the stimulus generator 490to a bodily tissue of a patient. Components of the stimulator assembly495 can be similar in many respects to components of apparatus shown anddescribed herein (e.g., components of electrode-battery assembly 100,apparatus 200, stimulation system 370, 570).

The housing 465, which is a substantially flexible housing, isconfigured to be disposed about at least a portion of a stimulatorassembly 495 (e.g., the base 472). Similarly stated, the housing 465 hasa low resistance to deflection, deformation and/or displacement whenexposed to an external force. In this manner, the housing 465 can bedisposed about other portions of the stimulator assembly 495 such thatthe housing 465 substantially conforms to the shape of one or more ofthe other portions of the stimulator assembly (e.g., the protrusion 476,the stimulus generator 490, or the like). In some embodiments, theflexible housing 465 is configured to substantially prevent access ofmoisture to the portion of the stimulator assembly 495 about which theflexible housing 465 is disposed.

The flexible housing 465 includes a receiving portion 466, which isconfigured to receive at least a portion of the stimulus generator 490.The receiving portion 466 defines a first opening 468 (see FIG. 40) anda second opening 469 (see FIG. 39) different than the first opening. Thefirst opening 468 is configured to receive a protrusion 491 of thestimulus generator 490. The protrusion 491 of the stimulus generator 490can include, for example, one or more electrical contacts 493 configuredto place the stimulus generator 490 in electrical communication withother portions the stimulator assembly 495 (e.g., the battery 494, theelectrode 497). The electrical contacts 493 can be any suitablemechanism for electrically coupling the stimulus generator 490 withother portions the stimulator assembly 495. In some embodiments, theelectrical contacts 493 are biased to help retain the stimulus generator490 to the housing 465 and/or the stimulator assembly 495. For example,the electrical contacts 493 can include a spring, which may also beconfigured to transmit an electrical current between the stimulusgenerator 490 and the stimulator assembly 495, an elastomer, or othersuitable biasing mechanism, or any combination of the foregoing.

The second opening 469 of the flexible housing 465 is configured toreceive a protrusion 476 of the base 472. The base 472 can be similar tothe base 372 and/or the base 172 shown and described above. As describedin more detail herein, the protrusion 476 of the base 472 is configuredto couple the stimulus generator 490 to the housing 465 and othercomponents of the stimulator assembly 495. Although the first and secondopenings 468, 469 of the housing 465 are illustrated as being defined byopposing ends of the receiving portion 466, in other embodiments, thefirst opening and/or the second opening can be defined by a differentportion of the receiving portion.

As shown in FIG. 42, the housing 465 also defines a recess 464configured to receive a fastening member 474 (shown in FIG. 39) of thebase 472. A portion of the housing 465 has been removed in FIG. 42 forillustrative purposes only. The fastening member 474 can include endportions 475, 475′, each of which are configured to be received inrespective openings 467, 467′ defined by the housing 465. The endportions 475, 475′ are each configured to facilitate coupling of thehousing 465 to the stimulator assembly 495 when the end portions 475,475′ are received in the openings 467, 467′. As such, when the flexiblehousing 465 is disposed about at least a portion of the stimulatorassembly 495 and the fastening member 474 is received in the recess 464,as illustrated in FIG. 40, movement of the housing 465 relative to otherportions of the stimulator assembly 495 is limited. In other words, thefastening member 474 is configured to couple or fasten the housing 465to the other portions of the stimulator assembly 495 in a manner suchthat the lateral and/or vertical movement of the housing 465 withrespect to the stimulator assembly 495 in the presence of substantiallynormal physical activities (e.g., walking, bathing, or the like) issubstantially restricted.

When the fastening member 474 fastens the housing 465 to the remainderof the stimulator assembly 495, the protrusion 476 of the base 472 isreceived within the opening 469 of the receiving portion 466. Theprotrusion 476 is configured to limit movement of the stimulus generator490 with respect to the housing 465 when the stimulus generator isreceived in the receiving portion 466 of the housing. In use, when thestimulator generator 490 is received in the receiving portion of thehousing 465 and the protrusion 491 of the stimulus generator is receivedin the opening 469, the protrusion 476 of the base 472 engages a portionof the stimulus generator 490. For example, as illustrated in FIG. 39,the protrusion 476 engages a recess 492 defined by the stimulusgenerator 490 when the stimulus generator 490 is received in thereceiving portion 466 of the housing 465. In some embodiments, theprotrusion 476 is resiliently biased towards the portion of the stimulusgenerator 490. In this manner, the protrusion 476 retains the stimulusgenerator 490 with respect to the housing 465 when the stimulusgenerator 490 is received in the receiving portion 466 of the housing,and thus limits movement of the stimulus generator 490 with respect tothe housing 465. Said another way, the resistance that occurs byengagement of the protrusion 476 with the portion of the stimulusgenerator 490 facilitates coupling of the stimulus generator 490 to thehousing 465. The protrusion 476 is configured to release the stimulusgenerator 490 when the protrusion 476 is pushed, depressed, or otherwisemoved by the operator (e.g., a physician or the patient).

Although the recess 492 is illustrated as being on an end of thestimulus generator 490 that is opposite to an end of the stimulusgenerator including the protrusion 491, in other embodiments, the recess(or other portion configured to engage protrusion 476) can be defined bya different portion of the stimulus generator.

When the stimulus generator 490 is received in the receiving portion 466and the protrusion 491 of the stimulus generator is received in theopening 468, the stimulus generator 490 is electrically coupled to thebattery 494. In some embodiments, the stimulus generator 490 iselectrically coupled to the battery 494 via an electrical circuit 485disposed on the substrate 480 in a similar manner as described abovewith reference to the portion of the stimulation system 370. Theelectrical circuit 485 includes at least one electrical pathway 487.More particularly, when the protrusion 491 of the stimulus generator isreceived in the opening 468, the electrical contacts 493 are placed incontact with the electrical circuit 485. The battery 494 is also inelectrical connection with the electrical circuit 485, as describedabove, and thus the battery 494 is placed in electrical communicationwith the stimulus generator 490. In other words, the electrical circuit485 electrically couples the stimulus generator 490 to the battery 494.The electrical circuit 485 can also electrically couple the stimulusgenerator 490 to the electrode 497, as described above. The housing 465is configured to substantially maintain the stimulus generator 490 inelectrical communication with the electrical circuit 485 when thestimulus generator 490 is received in the receiving portion 466 and thehousing 465 is disposed about at least a portion of the substrate 480 ofthe stimulator assembly 495.

A portion of the housing 465 is configured to form a substantiallyfluid-tight seal proximate to the receiving portion 466 when the atleast a portion of the stimulus generator 490 is received in thereceiving portion 466. In some embodiments, the housing 465 can form aseal to substantially prevent passage of a fluid from an area exteriorto the housing and the stimulus generator 490 to an area interior to thehousing 465 and/or an area between the housing 465 and the stimulusgenerator 490 (e.g. between a perimeter of the receiving portion 466 andthe stimulus generator). In another example, the housing 465 can form aseal about the opening 468 when the protrusion 491 of the stimulusgenerator 490 is received in the opening to substantially preventpassage of a fluid therethrough. The fluid can be, for example, aliquid, a slurry, a gas, or the like. Thus, the housing 465 and/or thestimulator assembly 495 can be characterized as being water-resistant.

The housing 465 can be constructed from any suitable material to providethe desired flexibility, sealing properties or the like. In someembodiments, the housing 465 can be constructed from a polymer or rubbercompound having a modulus of elasticity and/or a flexural modulus ofless than approximately 750,000 p.s.i. In some embodiments, the housing465 can be constructed of an elastomer. The elastomer can be injectionmolded, e.g., from a bio-compatible material. In some embodiments, theelastomer has a mechanical elasticity of about 40 Shore D. Thus, thehousing is soft and flexible, which facilitates compliance with acurvature of the patient's body and which facilitates accuratepositioning of rigid parts of the stimulator assembly 495 (e.g., thebattery 494, the stimulus generator 490) on the patient's body. Forexample, in some embodiments, the housing 465 exhibits a degree offlexibility that permits the housing 465 to be placed substantiallyabout a surface of a radial body part of the patient (e.g., an arm, aleg, or other limb). Although the housing 465 is described herein asbeing constructed of an elastomer, in other embodiments, the housing 465can be constructed of any suitable material, including, for example, asilicon, polyamide, or another suitable polymer, or any combination ofthe foregoing.

The housing 465 can be disposed on or coupled to the body of the patientin any suitable known manner. For example, the housing 465 can becoupled to the body using a medical plaster, which may be beneficial forlarger bodily areas, including an abdomen or a backside of a shoulder.In another example, the housing 465 can be coupled to the body of thepatient using a band, which may be beneficial for parts of the patient'sbody having a substantially circular cross-section (e.g., the arm, leg,or other limb). Use of the band also permits easy attachment,detachment, and repositioning of the housing 465 on the body of thepatient.

In some embodiments, as illustrated in FIG. 52, a housing 190 can beconfigured to prevent migration and/or displacement of an electrode(e.g., a hydrogel electrode, not shown in FIG. 52,) with respect to thehousing in the presence of a shearing force and/or a mechanical stress.The housing 190 includes a flange 194 that extends from a body portion196 of the housing to form a channel 198. In some embodiments, asillustrated in the cross-sectional view of the housing 190 shown in FIG.52, the flange 194 forms a substantially continuous rim about a lowerportion of the body portion 196 of the housing 190. In otherembodiments, however, the housing can include a plurality of discreteflanges, which collectively form a discontinuous and/or non-contiguousrim about the lower portion of the body portion of the housing. Forexample, the housing can include two or more flanges disposed on thebody portion at spaced (e.g., opposing) locations.

The channel 198 is configured to receive a portion of the periphery (oredge) of the electrode. In the embodiment illustrated in FIG. 52, thechannel 198 is substantially U-shaped, however, in other embodiments,the channel can be any suitable shape for receiving a portion of theperiphery of the electrode. When the peripheral portion of the electrodeis received in the channel 198 of the flange 194, lateral movement ofthe electrode relative to the housing is restricted. In this manner, thehousing 190 is configured to couple the electrode to the housing, andthus to a stimulator assembly (not shown in FIG. 52) to which thehousing is attached.

Although the flange 194 and channel 198 have been illustrated anddescribed herein as being integrally formed with the housing 190, inother embodiments, the electrode rim, or a portion thereof, can bemanufactured as a separate and distinct portion that is couplable to thehousing.

Further, although the housing 190 has been illustrated and describedherein as including the electrode rim, in other embodiments, theelectrode rim can be included in or coupled to a different portion ofthe stimulator assembly. For example, as illustrated in FIG. 53, astimulator assembly 289 includes a rim 290, which is removably couplableto a base 246 of the stimulator assembly, as described herein. The rim290 includes a body portion 296 and a flange 294. The flange 294 of therim 290 is extended from the body portion 296 and forms a channel 298between the flange and the body portion. The flange 294 is disposedabout a portion of a periphery of at least one electrode 299 (e.g., ahydrogel electrode) such that a portion of the electrode's periphery 297is received in the channel 298. In some embodiments, the electrode 299is fixedly received in the channel 298 of the rim 290. In otherembodiments, the electrode 299 is removably received in the channel 298of the rim 290. The electrode 299 can be disposed within the channel 298of the rim 290 during the manufacturing process, e.g., to permitdistribution of the electrode and rim in a single package. Asillustrated in FIG. 53, a protrusion 247 of the base 246 includes arecess 248 that is configured to receive a portion of the body portion296 of the rim 290, and thus is configured to couple the rim 290 andelectrode 299 to the base 246. As such, the rim 290 facilitatesattachment, removal and/or replacement of the electrode 299 with respectto the stimulator assembly 289.

Although the rim 290 is shown and described above as being coupled tothe base using recess 248 of the protrusion 247 of the base, in otherembodiments, the rim 290 can be differently coupled to the base. Forexample, in some embodiments, the rim 290 can be coupled to the basewith an elastic configured to be disposed about a portion of the base, aclip, a hook and loop fastener, or an adhesive, or any combination ofthe foregoing.

Further, in other embodiments, the electrode rim can be configured to becoupled to a different portion of a stimulator assembly, including, butnot limited to, a substrate of the stimulator assembly. In still otherembodiments, an electrode rim can integrally formed with a base,substrate, or other suitable portion of a stimulator assembly.

FIGS. 43-47 illustrate a portion of a stimulation system 570 accordingto an embodiment. The portion of the stimulation system 570 isconfigured to deliver an electrical current from an electronic device(not shown) to a bodily tissue of a patient. The portion of thestimulation system 570 includes a substrate 580, a power source 594, acasing 592, electrodes 597, 599, an electrical circuit 585, a couplingmember 572, and a housing 565, each of which are coupled to or otherwisedisposed on the substrate 580.

The substrate 580 is flexible such that the substrate can substantiallyconform to the contours of the portion of the patient's body on whichthe portion of the stimulation system 570 is disposed. For example, thesubstrate 580 can be configured to be flexible such that the substrateconforms to the curvature of a patient's arm, leg, or back. In thismanner, the substrate 580 is configured to facilitate positioning andplacement of the stimulation system on the patient's body. In someembodiments, the substrate 580 can be similar to and/or constructed fromsimilar materials as any of the substrates shown and described herein.

The substrate 580 has a first configuration and a second configurationdifferent than the first configuration. In its first configuration, thesubstrate 580 has a first area (see, e.g., FIG. 45). Similarly stated,when the substrate 580 is in its first (or unfolded) configuration, thesubstrate 580 occupies a first surface area and/or defines a first“footprint.” When the substrate 580 is in its first configuration, eachof the electrodes 597, 599 and the electrical circuit 585 face a firstdirection and are disposed on a first side 581 of the substrate. Forexample, when the substrate 580 is in its first configuration and thesubstrate is positioned horizontally, the electrodes 597, 599 and theelectrical circuit 585 can be characterized as facing “up.”

In its second configuration, the substrate 580 has a second area lessthan the first area (see, e.g., FIGS. 46-47). Similarly stated, when thesubstrate 580 is in its second (or folded) configuration, the substrate580 occupies a second surface area and/or defines a second “footprint”that is smaller than the first “footprint.” When the substrate 580 is inits second configuration, the electrodes 597, 599 and at least a portionof the electrical circuit 585 each face a second direction differentthan the first direction, as illustrated in FIGS. 45-46. For example,when the substrate 580 is in its second configuration and the substrateis positioned horizontally, the electrodes 597, 599 and the portion ofthe electrical circuit 585 can be characterized as facing “down,” ortowards the bodily tissue, while the remaining portion of the electricalcircuit remains facing “up,” or away from the bodily tissue. Thesubstrate 580 can be moved from its first configuration to its secondconfiguration, for example, by folding under at least one of tab portion596 or tab portion 598, as shown in FIGS. 46-47, respectively. Becausethe substrate 580 is flexible, the substrate is not damaged (e.g.,cracked, broken, or creased) when the at least one of the tab portions596, 598 is folded under. Because the electrodes 597, 599 and theelectrical circuit 585 are formed on a first side 581 of the substrate580, manufacturing of the substrate 580 is more easily accomplished. Forexample, in some embodiments, the electrodes 597, 599 and/or electricalcircuit 585 can be formed by an electrically conductive ink printed ontothe first side of the substrate 580.

As illustrated in FIG. 44, the power source 594 is coupled to the firstside 581 of the substrate 580. The power source 594 can be any suitablesource of power for providing power to the electronic device, includingany source of power shown and described herein. For example, the powersource 594 can be a lithium battery, a rechargeable battery or the like.In some embodiments, the power source 594 provides enough power forapproximately one week of standard use by a patient. In otherembodiments, the power source 594 provides power for a longer period oftime.

The casing 592 includes a rim 593 and defines a cavity (not shown, butindicated by arrow 595). The power source 594 is received in the cavity595 of the casing 592. The rim 593 of the casing 592 is coupled to thesubstrate 580 to form a seal configured to substantially prevent thepassage of moisture between the rim 593 of the casing 592 and thesubstrate 580. In this manner, the casing 592 substantially preventsentry of moisture into the cavity 593, and thus onto the power source594 and/or the portion of the electrical circuit 585 coupled to thepower source. As such, the casing 592 can limit a short-circuit of thepower source 594 caused by exposure to moisture during the patient'sdaily activities, including bathing, perspiring, or swimming.

The electrical circuit 585 is configured to electrically couple each ofthe power source 594 and the electrodes 597, 599 to the electronicdevice. Each electrode 597, 599 is configured to contact a bodily tissue(either directly or via a secondary electrode), and to convey anelectrical current between the electronic device and the bodily tissue.In some embodiments, at least one electrode 597, 599 can be associatedwith a hydrogel electrode. For example, a hydrogel electrode can bebonded to the substrate surrounding the perimeter of the at least oneelectrode 597, 599 such that the hydrogel electrode is disposed over andin electrical communication with the at least one electrode 597, 599.

The coupling member 572 is coupled to the flexible substrate 580. Moreparticularly, the coupling member 572 defines a first slot 571 and asecond slot 573 different than the first slot. As illustrated in FIG.43, at least a first portion of the substrate 580 is disposed within thefirst slot 571, and at least a second portion of the substrate isdisposed within the second slot 573. In some embodiments, the couplingmember 572 is substantially rigid, and therefore provides support to theflexible substrate 580. In some embodiments, the coupling member 572 canbe similar in many respects to the base 372 described above with respectto the stimulation system 370.

The coupling member 572 also includes a connective member 574 and aprotrusion 576. The substrate 580 is coupled to the connective member574 such that a first portion 581′ of the first side 581 of thesubstrate 580 is non-parallel to a second portion 581″ of the first sideof the substrate, as illustrated in FIG. 43. A portion of the electricalcircuit 585 is disposed on the second portion 581″ of the first side 581of the substrate 580. Thus, the portion of the electrical circuit 585 isdisposed proximate to a portion of the electronic device when theelectronic device is coupled to the stimulation system 570, as describedin more detail herein.

The coupling member 572 is configured to receive at least a portion ofthe electronic device in an area between the connective member 574 andthe protrusion 576. The protrusion 576 of the coupling member 572 isconfigured to releasably couple the electronic device to the substrate580. In some embodiments, the protrusion 576 is configured to releasablyengage a recess of the electronic device (e.g., as shown and describedabove with respect to protrusion 476 and stimulus generator 490).

The housing 565 can be similar in many respects to housing 465 describedherein. The housing 565 is disposable over at least a portion of thesubstrate 580. The housing includes a receiving portion 566 and definesan opening 569. The receiving portion 566 is configured to receive atleast a portion of the electronic device. In some embodiments, thereceiving portion 566 is defined by a surface 567 of the housing. Theopening 569 of the housing 565 is configured to receive the protrusion576 of the coupling member 572. In this manner, the protrusion 576 isconfigured to releasably engage the recess of the electronic device whenthe electronic device is disposed in the receiving portion 566 of thehousing 565, and the protrusion 576 is received in the opening 569defined by the housing.

In use, when the electronic device is received in the receiving portion566 of the housing 565, the electronic device is placed in electricalcommunication with the electrical circuit 585. As such, the power source594 can provide power to the electronic device such that the electronicdevice can generate an electrical current. The electrical currentgenerated by the electronic device is transmitted from the electronicdevice to the electrical circuit 585. The electrical current is thentransmitted from the electrical circuit 585 to the electrodes 597, 599.The electrodes 597, 599 convey the electrical current to the bodilytissue, thereby providing stimulation to the bodily tissue. In someembodiments, the electrodes 597, 599 are also configured to receive theelectrical current from the bodily tissue, and to transmit theelectrical current to the electronic device via the electrical pathway.In some embodiments, the stimulation system 570, or a portion thereof,is disposable. For example, the stimulation system 570 can be disposedof once the power source 594 is depleted and/or once the hydrogelelectrode is no longer suitable for use (e.g., after approximately twoweeks of continuous use). The usable life of the hydrogel electrode canbe extended, however, if the electrode is stored properly when not inuse (e.g., by applying a liner foil to the electrode to protect thehydrogel from humidity changes).

In some embodiments, however, the power source is removable and/orreplaceable, for example when the power source is low or depleted afteruse. As illustrated in FIGS. 54-55, a stimulator assembly 860 accordingto an embodiment is configured to transmit electrical stimulation to abody of a patient and includes a flexible housing 880, a stimulusgenerator 862, and a removable power source 870.

The stimulus generator 862 can be similar in many respects to thestimulus generator 490, described above. The housing 880 includes afirst receiving portion 881, which is configured to receive a portion ofthe stimulus generator 862. The stimulus generator 862 can be removablycoupled to the housing 880 in any suitable manner described herein. Forexample, the stimulus generator 862 can be coupled to the housing 880when the portion of the stimulus generator 862 is received in the firstreceiving portion 881 and a protrusion 865 of a base (not shown) of thestimulator assembly 860 engages a recess 863 of the stimulus generator.

The housing 880 defines a second receiving portion 882, which isconfigured to receive a portion of the power source 870, different thanthe first receiving portion 881. The receiving portions 881, 882 can besimilar in many respects to receiving portion 466 described above. Forexample, the second receiving portion 882 defines a first opening (notshown in FIGS. 54-55) that is configured to receive a protrusion 874 ofthe power source 870. The protrusion 874 of the power source 870 caninclude, for example, one or more electrical contacts configured toplace the power source 870 in electrical communication with otherportions the stimulator assembly 860 (e.g., the stimulus generator 862,an electrical pathway, an electrode). The electrical contacts can be anysuitable mechanism for electrically coupling the power source 870 withother portions the stimulator assembly 860. In some embodiments, theelectrical contacts are biased to help retain the power source to thehousing 880 and/or the stimulator assembly 860. For example, theelectrical contacts can include a spring, an elastomer, or othersuitable biasing mechanism.

The second receiving portion 882 also defines a second opening (notshown in FIGS. 54-55), which is configured to receive a protrusion 866of a base 864 (shown in dashed lines in FIG. 54) of the stimulatorassembly 860. The base 864 can be similar in many respects to the base472, base 372 and/or the base 172 shown and described above.

The protrusion 866 of the base 864 is configured to couple the powersource 870 to the housing 880 and other components of the stimulatorassembly 860. Specifically, the protrusion 866 is configured to limitmovement of the power source 870 with respect to the housing 880 whenthe power source is received in the receiving portion 882 of thehousing. In use, when the power source 870 is received in the receivingportion of the housing 880 and the protrusion 874 of the power source isreceived in the first opening of the housing, the protrusion 866 of thebase 864 engages a portion of the power source. For example, asillustrated in FIG. 54-55, the protrusion 866 engages a recess 876defined by the power source 870 when the power source is received in thereceiving portion 882 of the housing 880. In some embodiments, theprotrusion 866 is resiliently biased towards the portion of the powersource 870. In this manner, the protrusion 866 retains the power source870 with respect to the housing 880 when the power source is received inthe receiving portion 882 of the housing, and thus limits movement ofthe power source with respect to the housing 880. Said another way, theresistance that occurs by engagement of the protrusion 866 with theportion of the power source 870 facilitates coupling of the power sourceto the housing 880. The protrusion 866 is configured to release thepower source 870 when the protrusion 866 is pushed, depressed, orotherwise moved by the operator (e.g., a physician, patient, or otheruser). Although the recess 876 is illustrated as being on an end of thepower source 870 that is opposite to an end of the power sourceincluding the protrusion 874, in other embodiments, the recess (or otherportion configured to engage protrusion 866) can be defined by adifferent portion of the power source.

Because the power source 870 is removable the operator can remove thepower source from the stimulator assembly 860, for example, when thepower source is depleted or otherwise insufficiently charged. Afterremoval of the power source 870, a replacement power source of similarconstruct can be coupled to the stimulator assembly 860. In someembodiments, the power source 870 is also rechargeable. As such, atleast a portion of the power source 870 is configured to be coupled toan external charging station, e.g., after removal from the stimulatorassembly 860. While the power source 870 is being recharged, a secondpower source of similar construct can be used with the stimulatorassembly 860, thus allowing for substantially uninterrupted treatmentfor the patient. Once the power source 870 is recharged to a sufficientpower level and/or the secondary power source is depleted, the powersource 870 can be re-coupled to the stimulator assembly 860.

Because each of the power source 870 and the stimulus generator 862 areremovably couplable to the housing 880, in some embodiments, the housingand/or other portions of the stimulator assembly 860 (e.g., anelectrical pathway, an electrode) can be disposable. In this manner, theoperator can selectively replace, for example, a used electrode coupledto the housing with another housing including an unused electrode. Alsoin this manner, manufacturing costs for the stimulator assembly 860 canbe reduced because the power source 870 and/or stimulus generator 860are reusable instead of being disposed with the housing 880.Furthermore, the power source 870 and stimulus generator 862 can be usedwith another stimulator assembly having a footprint (i.e., theconfiguration of a portion of the stimulator assembly facing a patient'sbody) that is different than a footprint of the stimulator assembly 860and that includes a receiving portion configured to receive at least oneof the power source and stimulus generator. As such, at least one of thepower source 870 and stimulus generator 862 can be configured for usewith a housing adapted to a specific anatomical location (e.g., ashoulder, a knee, a lower back).

When the power source 870 is received in the receiving portion 882 andthe protrusion 874 of the power source is received in the first openingof the housing, the power source is electrically coupled to the stimulusgenerator 862. In some embodiments, the power source 870 is electricallycoupled to the stimulus generator 862 via an electrical pathway (notshown in FIGS. 54-55) disposed on a substrate (not shown in FIGS. 54-55)of the stimulator assembly 860 in a similar manner as shown anddescribed above with reference to substrate 380. More particularly, whenthe protrusion 874 of the power source 870 is received in the opening ofthe housing 880, the electrical contacts are placed in contact with theelectrical pathway. The stimulus generator 862 is also in electricalconnection with the electrical pathway, and thus is placed in electricalcommunication with the power source 870. In other words, the electricalpathway electrically couples the stimulus generator 862 to the powersource 870. The housing 880 is configured to substantially maintain thepower source 870 in electrical communication with the electrical pathwaywhen the power source is received in the receiving portion 882 and thehousing 880 is disposed about at least a portion of the substrate of thestimulator assembly 860. The housing 880 can be constructed of anysuitable material, including those materials described above withrespect to housing 465.

In some embodiments, the power source 870 includes a battery (not shown)and a casing 871. The battery is received in a cavity (not shown) of thecasing 871. The casing 871 can be configured to substantially preventthe passage of moisture between an area external to the casing 871 andthe cavity of the casing. In this manner, the casing 871 substantiallyprevents entry of moisture into the cavity, and thus onto the battery.As such, the casing 871 can limit a short-circuit of the battery causedby exposure to moisture during the patient's daily activities, includingbathing, perspiring, or swimming. The casing 871 also can help preventinadvertent disconnection of the battery caused by friction that occursduring the patient's daily activities, including walking or dressing.

In some embodiments, the casing 871 includes a panel (not shown) movablebetween an open position, in which the cavity is accessible from an areaexternal to the casing, and a closed position, in which the cavity issealed and/or otherwise inaccessible from an area external to thecasing. When the panel of the casing 871 is in its open position, thebattery can be removed from and/or inserted into the cavity, e.g., toremove and/or replace a depleted battery. In some embodiments in whichthe power source 870 is rechargeable, at least one of the casing 871 orthe battery is configured to be coupled to an external charging station.The battery can be any suitable source of power described herein,including as described above with respect to battery 394.

Although the power source 870 has been illustrated and described hereinas being coupled to the stimulator assembly 860 with protrusion 866 ofthe base 882, in other embodiments, the power source can be coupled tothe stimulator assembly in a different manner, for example, as shown anddescribed above with respect to apparatus 951.

Although stimulator system 570 and stimulator assembly 860 have beendescribed herein as being wholly disposable or having a disposablehousing, respectively, in other embodiments, a stimulator system caninclude a different disposable portion and/or reusable portion.Schematically illustrated in FIG. 56, a stimulator system 1000 accordingto an embodiment is configured to generate and transmit electricalstimulation through a bodily tissue of a patient. The stimulator system1000 includes a stimulator assembly 1010 removably coupled to anelectrode assembly 1040. Components of the stimulator system 1000 can besimilar in many respects to components of apparatus shown and describedherein (e.g., components of apparatus 100, 200, stimulation system 370,570, stimulator assembly 495, 860). Referring to FIG. 56, the stimulatorassembly 1010 includes a housing 1012, an electrical pathway 1014, afirst connector assembly 1016, a stimulus generator 1020, and a powersource 1030.

The stimulus generator 1020 is configured to generate the electricalstimulation. The stimulus generator 1020 can be similar in many respectsto any stimulus generator described herein (e.g., external stimulatorS₁-S₁₁, stimulus generator 490, 862), except that the stimulus generatorneed not be configured to be external and/or removable. In other words,the stimulus generator 1020 can include internal components configuredto generate the electrical stimulation similar to the internalcomponents of any stimulus generator described herein, but need not havean external casing, generally, or an external casing that is removablycouplable to the housing, specifically. For example, in someembodiments, the stimulus generator 1020 includes various electroniccomponents that collectively are configured to generate the electricalstimulation and that are collectively disposed within the housing 1012(e.g., on a substrate, not shown). The stimulus generator 1020 iselectrically coupled to the power source 1030 via the electrical pathway1014. The stimulus generator 1020 is also electrically couplable to theelectrode assembly 1040 via the electrical pathway 1014 and via thefirst connector assembly 1016.

The power source 1030 is configured to provide power to the stimulusgenerator 1020 via the electrical pathway 1014. The power source 1030 isconfigured to be rechargeable. More specifically, in some embodiments,the power source 1030 is configured to be recharged when the powersource is enclosed within the housing 1012. The power source 1030 isconfigured to be in electrical communication with an external charger(not shown in FIG. 56) by the electrical pathway 1014 and the firstconnector assembly 1016. The power source can be any suitable energysupplying source that may or may not be rechargeable. For example, insome embodiments, is a conventional disposable battery. In someembodiments, the power source is a rechargeable battery. Specifically,the power source can be a Li-polymer battery (e.g., a 500 mAh Li-polymerbattery). In some embodiments, the power source is a rechargeableversion of any suitable source of power described herein.

The power source 1030 is configured to provide power to the stimulusgenerator 1020 over a long duration of time, with recharging. Forexample, in some embodiments, the power source 1030 is configured toprovide power to the stimulus generator 1020 over a period of at leastsix months of standard use by a patient, with recharging. In someembodiments, the power source 1030 is configured to provide power over aperiod of at least one year, with recharging. In some embodiments, thepower source 1030 is configured to provide power over a period of abouttwo years, with recharging. In other embodiments, the power source 1030is configured to provide power to the stimulus generator 1020 for aperiod of less than six months of standard use by the patient. Forexample, in some embodiments, the power source 1030 is configured toprovide power to the stimulus generator 1020 over a period of about onemonth, with recharging. In another example, in some embodiments, thepower source 1030 is configured to provide power over a period of aboutone week, with recharging.

The power source 1030 is configured to provide power to the stimulusgenerator 1020 for a shorter duration on a single charge (i.e., beforebeing depleted to a level insufficient to power the stimulus generator1020). For example, in some embodiments, the power source 1030 isconfigured to provide power for up to twelve hours on a single charge.In other embodiments, the power source 1030 is configured to providepower to the stimulus generator 1020 for at least twelve hours on asingle charge. For example, in some embodiments, the power source 1030is configured to provide power to the stimulus generator 1020 for atleast twenty-four hours on a single charge. In another example, in someembodiments, the power source 1030 is configured to provide power forforty-eight or more hours on a single charge. In still another example,in some embodiments, the power source 1030 is configured to providepower for more three, four, or more days on a single charge. Althoughthe stimulator assembly 1110 has been illustrated and described hereinas including a permanent rechargeable power source 1130, in otherembodiments, a stimulator assembly can include a replaceable powersource (e.g., as described above with respect to power source 870).

The first connector assembly 1016 is configured to electrically couplethe stimulator assembly 1010 to the electrode assembly 1040. Asillustrated in FIG. 56, the first connector assembly 1016 iselectrically coupled to the stimulus generator 1020 and the power source1030. In some embodiments, the first connector assembly 1016 isconfigured to provide both a mechanical and an electrical connectionbetween the stimulator assembly 1010 and the electrode assembly 1040.Said another way, when the stimulator assembly 1010 is mechanicallycoupled to the electrode assembly 1040 via the first connector assembly1016, the stimulator assembly 1010 is also placed in electricalcommunication with the electrode assembly 1040. The first connectorassembly 1016 can include any suitable mechanism for electrically and/ormechanically connecting the stimulator assembly 1010 to the electrodeassembly 1040, including but not limited to, a snap-fit connector. Insome embodiments, the first connector assembly 1016 includes a metalelectrode. In some embodiments, the first connector assembly 1016includes a conductive ink, a wire, or the like. In some embodiments, thefirst connector assembly 1016 is formed in a unique shape to ensure thatonly electrodes with a corresponding-shape connector (e.g., secondconnector assembly 1044, described below) can be coupled to the housing1012. Such a configuration can also ensure that the housing 1012 iscoupled to the electrode in a pre-determined orientation.

The first connector assembly 1016 is configured to electrically couplethe power source 1030 to an external charger (not shown in FIG. 56). Insome embodiments, the first connector assembly 1016 is configured tomechanically couple the power source 1030 to the external charger. Insome embodiments, the first connector assembly 1016 is configured toboth electrically and mechanically couple the power source 1030 to theexternal charger. The first connector assembly 1016 can include anysuitable mechanism for electrically coupling the power source 1030 tothe external charger, including, but not limited to, a mechanismdescribed above with respect to connections between the stimulatorassembly 1010 and the electrode assembly 1040. In some embodiments, thefirst connector assembly 1016 includes at least a first connector (notshown) configured to electrically and/or mechanically couple thestimulator assembly 1010 to the electrode assembly 1040 and a secondconnector (not shown) different than the first connector and configuredto electrically and/or mechanically couple the stimulator assembly tothe external charger. In this manner, in some embodiments, thestimulator assembly 1010 is configured to be simultaneously connected toboth the electrode assembly 1040 and the external charger.

In some embodiments, the stimulator assembly 1010 is configured toprevent generation and/or transmission of the electrical stimulation tothe electrode assembly 1040 when the stimulation assembly is connectedto the external charger. In some embodiments, for example, the firstconnector assembly 1016 is configured to only permit an electricaland/or mechanical connection between the power source 1030 and theexternal charger when the stimulator assembly 1010 is not electricallyconnected to the electrode assembly 1040. For example, a connector (notshown) of the first connector assembly 1016 can be configured forconnection with each of the electrode assembly 1040 and the externalcharger such that when the connector is connected to one of theelectrode assembly or the external charger it is prevented from beingsimultaneously connected to the other of the electrode assembly or theexternal charger. In other words, the connector is shared between theelectrode assembly 1040 and the external charger. As such, when theconnector of the first connection assembly 1016 is connected to theexternal charger, it is prevented from also being connected to theelectrode assembly 1040. In other embodiments, the external charger isconfigured to physically interfere with a connection between thestimulator assembly 1010 and the electrode assembly 1040 when theexternal charger is connected to the stimulation assembly. In stillother embodiments, the stimulator assembly 1010 can include additionalhardware, software, or a combination thereof, configured to preventsimultaneous charging of the power source 1030 and transmission of theelectrical stimulation to the electrode assembly 1040.

The first connector assembly 1016 is disposed proximate to a bottomportion 1013 of the housing 1012. In some embodiments, for example, theconnector is substantially enclosed within a cavity 1015 of the housing1012. In some embodiments, the first connector assembly 1016 is disposedon an outer surface of the bottom portion 1013 of the housing 1012, suchthat the first connector assembly is exterior to the cavity 1015 of thehousing. In still other embodiments, a portion of the first connectorassembly 1016 is enclosed within the cavity 1015 of the housing 1012 andanother portion of the first connector assembly is exterior to thehousing 1012.

The electrical pathway 1014 is configured to electrically couple thefirst connector assembly 1016 to the at least one of the stimulusgenerator 1020 and the power source 1030. In some embodiments, forexample, the electrical pathway 1014 includes a wire configured toelectrically connect the stimulus generator 1020 and the power source1030. In some embodiments, a portion of the electrical pathway 1014 is apathway of conductive ink printed onto a substrate (not shown in FIG.56). The substrate can be, for example, any suitable substrate describedherein (e.g., substrate 102, PCB 202, flexible substrate 380, 580). Inanother example, the substrate can be substantially rigid (e.g., havelittle to no compliance to a bodily curvature). In some embodiments, atleast one of the electrical pathway 1014, the first connector assembly1016, the stimulus generator 1020, and the power source 1030, or anycombination thereof, is coupled to the substrate.

The housing 1012 is configured to at least partially enclose componentsof the stimulator assembly 1010, such as, but not limited to, thestimulus generator 1020, the power source 1030, the electrical pathway1014, the first connector assembly 1016, the substrate, or the like. Inthis manner, the housing 1012 is configured to protect the enclosedcomponents from external contaminants, including, for example, exposureto dirt, moisture, fluids, and the like. In some embodiments, thehousing 1012 defines an opening (not shown in FIG. 56) configured toprovide access to a portion of the first connector assembly 1016. Insome embodiments, such as when at least a portion of the first connectorassembly 1016 is external to the housing 1012 cavity 1015, the housingis disposed about the portion of the first connector assembly in such amanner as to provide a seal between the cavity and an area exterior tothe cavity.

The housing 1012 is configured to be durable (e.g., by being constructedof durable materials). For example, the housing 1012 is configuredwithstand being bumped, exposed to moisture (e.g., humidity, sweat), andthe like that occur during normal daily activities (e.g., walking,shopping). It is desirable that the housing 1012, and the stimulatorassembly 1010 generally, be configured for use in normal dailyactivities by a patient for a period of about two years. The housing1012 can be constructed of any suitable material, including, but notlimited to, any suitable material, or combination of materials,described herein (e.g., with respect to housing 465).

In some embodiments, the stimulator assembly 1010 is configured to alertthe user when the power source 1030 has been depleted to a thresholdlevel. For example, in some embodiments, the stimulator assembly 1010 isconfigured to provide an audible alert (e.g., a beep, a recorded verbalwarning), a tactile alert (e.g., a vibration), a visual alert (e.g., alight or other visual indicia), or a combination thereof, when the powersource 1030 has been depleted to the threshold level. In someembodiments, the stimulator assembly 1010 is programmable, for example,so that the threshold level can be set by an operator (e.g., aphysician, the patient, etc.).

The electrode assembly 1040 of the stimulator system 1000 is removablycouplable to the stimulator assembly 1010, as shown in FIGS. 56-57. Insome embodiments, the electrode assembly 1040 is configured to becoupled to the housing 1012 proximate to the bottom portion 1013 of thehousing. The electrode assembly 1040 includes at least one electrode1042 and a second connector assembly 1044. In some embodiments, thesecond connector assembly 1044 of the electrode assembly 1040 isconfigured to be mechanically and/or electrically coupled to the firstconnector assembly 1016 of the stimulator assembly 1010. In someembodiments, the second connector assembly 1044 is configured to provideboth a mechanical and an electrical connection between the electrodeassembly 1040 and the stimulator assembly 1010. The second connectorassembly 1044 can include any suitable mechanism for electrically and/ormechanically connecting the stimulator assembly 1010 to the electrodeassembly 1040. For example, the first connector assembly 1016 and thesecond connector assembly 1044 can include complementary (or mating)connectors (e.g., snap-fit connectors). In some embodiments, the secondconnector assembly 1044 includes a metal electrode. In some embodiments,the second connector assembly 1044 includes a conductive ink, a wire, orthe like.

The electrode assembly 1040 is configured to receive the electricalstimulation from the stimulator assembly 1010 via the coupled connectorassemblies 1016, 1044. The second connector assembly 1044 is configuredto transmit the electrical stimulation to the electrode 1042. Theelectrode 1042 is configured to facilitate transmission of theelectrical stimulation through the bodily tissue. The electrode 1042 isconfigured to contact bodily tissue. For example, in some embodiments,the electrode assembly 1040 includes a hydrogel electrode configured toadhere to the patient's skin. The electrode assembly 1040 can remain incontact with (or adhered to) the bodily tissue when the stimulatorassembly 1010 is decoupled from the electrode assembly 1040.

The electrode assembly 1040 is disposable. For example, the electrodeassembly 1040 can be disposed of once the electrode is no longersuitable for use (e.g., after approximately two weeks of continuoususe). In use, the electrode assembly 1040 is decoupled from thestimulator assembly 1010 before being discarded. In this manner, thestimulator assembly 1010 can continue to be used with a replacementelectrode assembly.

The electrode assembly 1040 can be of any desired shape, size, orfootprint. For example, in some embodiments, the electrode assembly isconfigured to be positioned at a specific anatomical location, such as alower back (FIG. 58A), a shoulder (FIG. 58B), an elbow (FIG. 58C), or aknee (FIG. 58D). In this manner, the electrode assembly 1040 isconfigured to comply with bodily curvature, which may facilitateadhesion of the electrode 1042 to the bodily tissue. As such, theelectrode assembly 1040 may help eliminate the need for sleeves tomaintain the assembly adjacent the desired bodily tissue. In someembodiments, the footprint of the electrode assembly 1040 is determinedby a shape, size, or footprint of the electrode 1042.

Although the electrode assembly 1040 has been illustrated and describedherein as being configured to adhere to the bodily tissue, in someembodiments, a stimulation system includes an electrode assemblyconfigured to be coupled to the bodily tissue in another manner. In someembodiments, a stimulation system includes an electrode assemblyconfigured to be coupled to the bodily tissue by a garment. The garmentis configured to maintain the electrode assembly at a desired positionwith respect to the bodily tissue. In some embodiments, the garment isconfigured to be securely wrapped about a portion of the stimulationsystem (e.g., the electrode assembly, a stimulation assembly, or boththe electrode and stimulation assemblies). For example, in use, theelectrode assembly can be disposed at the desired position with respectto the bodily tissue and then garment can be securely wrapped about theelectrode assembly (and, optionally, about a portion of the patient'sbody) to couple the electrode assembly to the bodily tissue. The garmentcan define an opening, for example, to permit access to a connectorassembly of the electrode assembly. In this manner, a stimulatorassembly of the stimulation system can be coupled to the electrodeassembly when the electrode assembly is coupled to the bodily tissueusing the garment. In another example, the stimulator assembly andelectrode assembly can be coupled together and disposed at the desiredposition with respect to the bodily tissue, and the garment can bedisposed about the coupled stimulator and electrode assemblies so thatthe electrode assembly is coupled to the bodily tissue.

In some embodiments, the garment includes at least a portion of thestimulation system. For example, in some embodiments, an electrodeassembly is included in the garment. As such, when the garment is donnedby the patient, the electrode assembly is also donned by the patient. Insome embodiments, the garment is configured to align the electrodeassembly at the desired position with respect to the bodily tissue. Thegarment can be, for example, a sleeve, a strap, a belt, a vest, or thelike. In other embodiments, an electrode assembly is coupled to a bodilytissue using a combination of an adhesive and a garment.

In some embodiments, as illustrated in FIGS. 59-61, a stimulator system1100 according to an embodiment is configured for use with an electricallead implanted into the patient's bodily tissue T. The stimulator system1100 and its components can be similar in many respects to stimulatorsystem 1000 and its respective components, described in detail above.The stimulator system 1100 includes a stimulator assembly 1110 (FIG. 59)and a disposable electrode assembly 1140 (FIG. 60). The stimulatorassembly 1110 includes a housing 1112, a stimulus generator 1120 (shownin dashed lines in FIG. 59), a power source 1130 (shown in dashed linesin FIG. 59), an electrical pathway (not shown), and a first connectorassembly (not shown). The stimulator assembly 1110 and its componentscan be similar in many respects to simulator assembly 1010 and itscomponents, described above. The stimulator assembly 1110 is removablycouplable to the electrode assembly 1140. Specifically, the electrodeassembly 1140 includes a second connector assembly 1144 removablycouplable to the first connector assembly of the stimulator assembly1110. The second connector assembly 1144 includes a first connector 1145and a second connector 1147. Each of the connectors 1145, 1147 isconfigured to be received by the first connector assembly. The electrodeassembly 1140 includes a first electrode 1142 and a second electrode1142. The electrodes 1142, 1143 can be any suitable electrode describedherein (e.g., electrode 1042).

As illustrated in FIG. 61, each of the first electrode 1142 and thesecond electrode 1143 is configured to contact the bodily tissue T andto facilitate transmission of an electrical stimulation E through thebodily tissue, for example through subcutaneous bodily tissue locatedbelow and/or between the first electrode and the second electrode. Thefirst electrode 1142 is configured to facilitate transmission of theelectrical stimulation E from the stimulator assembly 1110 through thebodily tissue T. The first electrode 1142 can facilitate transmission ofthe electrical stimulation E to an electrical lead L at least partiallyimplanted within the bodily tissue, as illustrated in FIG. 61. Forexample, in some embodiments, the first electrode 1142 is a cathodeconfigured to help transmit the electrical stimulation to a receiver (orpick-up) end of the electrical lead L. The second electrode 1143 isconfigured to receive at least a portion of the electrical stimulationE. As illustrated in FIG. 61, for example, the second electrode 1143 canreceive electrical stimulation E that has passed through the bodilytissue T and/or through the electrical lead L at least partiallyimplanted within the bodily tissue. For example, in some embodiments,the second electrode 1143 is an anode configured to receive at least aportion of the electrical stimulation E from a stimulating end of theelectrical lead L. In this manner, the stimulator system 1100 isconfigured to reduce loss of the electrical stimulation within thebodily tissue when the system is used with the implanted lead.Specifically, because the electrodes 1142, 1143 are positionable overthe pick-up end and stimulating end, respectively, of the electricallead L, the electrode assembly 1140 is configured to increase a pick-upratio of the electrical current C as compared to an electrode assemblywith a smaller footprint preventing the electrodes from being positionedproximate to ends of the electrical lead.

The electrodes 1142, 1143 are configured to adhere to bodily tissue(e.g., the skin) of the patient. Each electrode 1142, 1143 of theelectrode assembly 1140 includes a gel on the tissue-facing surface ofthe electrode. The gel can be any suitable known gel including, but notlimited to, wet gels, karaya-gum-based hydrogels, and/or syntheticcopolymer-based hydrogels. The first electrode 1142 and second electrode1143 can be, for example, a cathodic gel electrode and an anodic gelelectrode, respectively. Although the electrode assembly 1140 has beenillustrated and described herein as including two electrodes 1142, 1143,in other embodiments, an electrode assembly can include any suitablenumber of electrodes. For example, an electrode assembly can includethree, four, or more electrodes.

Although the electrode assembly 1140 has been illustrated and describedherein as including a connector assembly 1144 and two electrodes 1142,1143, in other embodiments, an electrode assembly can include additionalcomponents. For example, in some embodiments, an electrode assemblyincludes a support portion. The support portion can be configured toprovide additional structural support or reinforcement, for example, toa portion of the electrode(s). In another example, the support portioncan be configured to facilitate coupling of the electrode assembly tothe stimulator assembly. In yet another example, an electrode assemblycan include a tab configured to held by a user to facilitate removal ofthe electrode assembly from the bodily tissue.

Although the stimulus generator 1120 and the power source 1130 have beenillustrated and described as being spaced apart within the stimulatorassembly, in other embodiments, a stimulator assembly can include astimulus generator and a power source disposed in another configuration.For example, in some embodiments, a stimulator assembly can include astimulus generator that is disposed in a stacked configuration on top ofthe power source, or vice versa. In another example, in someembodiments, a stimulator assembly can include a stimulus generator anda power source that are disposed in close proximity to each other (e.g.,side by side within the housing). Any suitable design configuration ofthe stimulus generator and power source may be used. In this manner, thestimulator assembly can have a more compact configuration.

In use, the stimulator system 1100 is disposed on the target bodilytissue and stimulation of the bodily tissue is initiated by theoperator. The stimulator assembly 1110 can be removed from the electrodeassembly 1140 for bathing, swimming, or other activity, however theelectrode assembly can remain disposed on (or adhered to) the bodilytissue. Following the activity, the stimulator assembly 1110 isreattached to the electrode assembly 1140 and selective stimulation ofthe bodily tissue can be resumed. The stimulator assembly 1110 isgenerally removed from the electrode assembly 1140 and recharged dailyusing the external charger. After recharging, the stimulator assembly isreattached to the electrode assembly 1140. The electrode assembly 1140can be replaced on a weekly basis, or a needed. The stimulator assembly1110 can be replaced annually, bi-annually, or as needed, for example,when the power source 1130 will no longer maintain a charge sufficientfor powering the stimulus generator 1120 for a desired period of time.

FIG. 48 is a flow chart of a method 670 of assembling a portion of astimulator assembly according to an embodiment. The method includesfolding a tab portion of a flexible substrate such that the tab portionof the flexible substrate is in contact with a bottom side of a bodyportion of the flexible substrate and such that an electrical circuitformed on a top side of the flexible substrate extends about an edge ofthe fold, 675. The flexible substrate can be any substrate of the typesshown and described herein (e.g., PCB 202, PCB 792, substrate 380,substrate 480, substrate 580). In some embodiments, the tab portion ofthe flexible substrate is bonded to the bottom side of the body portionof the flexible substrate. The electrical circuit can be formed on thetop side of the flexible substrate in any manner shown and describedherein. For example, the electrical circuit can be printed on thesubstrate. In another example, the electrical circuit can be partiallyembedded in the substrate such that a portion of the electrical circuitis exposed on a surface of the substrate.

In some embodiments, the method optionally includes coupling a portionof the flexible substrate to a rigid base, 680. The base can be, forexample, any of the bases shown and described herein (e.g., base 372).The flexible substrate can be coupled to the rigid base in any suitablemanner. In some embodiments, for example, at least a portion of theflexible substrate is woven through one ore more openings defined by therigid base (e.g., similar to the coupling of substrate 380 and base 372shown and described above). The flexible substrate can, for example, bewoven through a set of slots defined by the base.

In some embodiments, the method optionally includes disposing a firstportion of the flexible substrate that includes the electrical circuitover a protrusion of the rigid base such that the first portion of theflexible substrate is non-parallel to a second portion of the flexiblesubstrate, 685. For example, in some embodiments, the flexible substrateis disposed over the protrusion of the base similar to the disposal ofsubstrate 380 over the protrusion 374 of the base 372 as shown anddescribed above.

In some embodiments, the method optionally includes folding a second tabportion of the flexible substrate such that the second tab portion ofthe flexible substrate is in contact with the bottom side of the bodyportion of the flexible substrate and such that the electrical circuitextends about an edge of the fold of the second tab portion, 690. Forexample, in some embodiments, the second tab of the flexible substratecan be folded such that the substrate is in the second configuration asillustrated in FIGS. 45-47 and described above with respect to substrate580.

Although the method 670 of assembling a portion of a stimulator assemblyhas been illustrated and described in one order, the activities canoccur in a different order. For example, in some embodiments, thesubstrate is coupled to the rigid base prior to folding the tab portionof the flexible substrate. Furthermore, each activity is not requiredfor assembling the portion of the stimulator assembly. For example, insome embodiments, a portion of the electrical circuit can be disposed onthe top and bottom side of the second tab portion, wherein the secondtab portion need not be folded to extend the electrical circuit about anedge of the fold of the second tab portion. Additionally, certain of theevents may be performed concurrently in a parallel process whenpossible.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. While the embodiments have been particularly shown anddescribed, it will be understood that various changes in form anddetails may be made. For example, although the apparatus have been shownand described above as including a certain number of electrodes, inother embodiments, any suitable number of electrodes can be included.Further, elements of each embodiment described herein may be combined inany suitable manner with one or more elements of another embodimentdescribed herein. For example, a hydrogel electrode may be selectivelyused with any of the foregoing apparatus, regardless if an embodimentwas specifically described as including a hydrogel electrode. In anotherexample, where an apparatus is shown and described herein as including amechanical connector for connection to an external stimulator, in otherembodiments, the apparatus can include a wireless connector forconnection to the external stimulator.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof the embodiments as discussed above. For example, a stimulation systemaccording to an embodiment can include a base similar to the base 372 asdescribed above and a folded substrate similar to the substrate 580 asdescribed above.

Thus, the breadth and scope of the invention should not be limited byany of the above-described embodiments, but should be defined only inaccordance with the following claims and their equivalents. The previousdescription of the embodiments is provided to enable any person skilledin the art to make or use the invention. While the invention has beenparticularly shown and described with reference to embodiments thereof,it will be understood by those skilled in the art that various changesin form and details may be made therein without departing from thespirit and scope of the invention.

An experiment was performed utilizing a first apparatus 990 and a secondapparatus 991 according to an embodiment of the invention, asillustrated in FIG. 49, to estimate the leakage current when each of thefirst apparatus and the second apparatus is immersed in solutionsencountered during daily activities. Apparatus 990 includes a firstmetal connector 992 and a second metal connector 994. Apparatus 991 wascut in the middle and the cut was filled with hot glue 997 to increaseimpedance between a first metal connector 993 and a second metalconnector 995, as illustrated in FIGS. 49 and 50. Impedance of bothdirect current (DC) and alternating current (AC) was measured betweenthe two metal connectors 992, 994 of the first apparatus 990. Impedanceof both DC and AC was measured between the two metal connectors 993, 995of the second apparatus 991 prior to submersion in the liquid. ACimpedance was measured between the two metal connectors 992, 994 of thefirst apparatus 990 while the first apparatus was attached to skin of apatient. AC impedance was measured between the two metal connectors 993,995 of the second apparatus 991 while the second apparatus was attachedto the skin of the patient.

Each of the first apparatus 990 and the second apparatus 991 wassubmerged in a liquid with a 3V Lithium coin battery attached to itsrespective metal connectors, as illustrated in FIG. 51 with reference toapparatus 991. The discharge current and voltage were each measured foreach apparatus 990, 991 when the apparatus was submerged. Each of thedischarge current, voltage and impedance were measured after removingthe each apparatus 990, 991 from its respective liquid submersion.Additionally, each of the discharge current, voltage and impedance weremeasured after slight wiping of the each apparatus 990, 991. Eachapparatus 990, 991 was then washed with tap water. These steps wereperformed for each of the following liquids: tap water, hot tub water,and saline solution. The discharge current showed an expected batterydischarge, while AC impedance may represent leakage of the stimulationcurrent on the patch rather than through bodily tissue. All AC impedancemeasurements were performed at 1 KHz. The results are shown in Table 1,below.

TABLE 1 Effects of Various Liquids on the Apparatus* Apparatus 990Apparatus 991 Battery Battery current Impedance leakage ImpedanceSubmersion in tap 1.5 mA 1.6 mA water Removal from tap 0.6 mA 2.0 Kohm0.1 mA ∞ Kohm water 27 nF 49 pF After wiping 0.3 mA 300 Kohm >0.1 mA  ∞Kohm 2.0 nF 30 pF Submersion in hot  2 mA 2.2 mA tub water Removal fromhot 0.8 mA 2.0 Kohm 0.07 mA  1.7 Kohm tub water 13 nF 1.2 nF Afterwiping 0.5 mA 90 Kohm >0.01 mA  230 Kohm 1.0 nF 128 pF (130 Kohm afterabsorbing water with napkin) Submersion in  9 mA  10 mA saline solutionRemoval from 0.4 mA 0.34 Kohm 0.04 mA  3.5 Kohm saline solution 212 nF1.7 nF After wiping 0.3 mA 0.5 Kohm >0.01 mA  230 Kohm 134 nF 94 nF*Before submersion, DC impedance approached infinity; AC impedance Rapproached infinity, C = pF; Impedance on the skin (AC) R = 8.3 Kohm, C= 36 nF. Battery voltage (when connected to the immersed patch) was2.8-2.9 v.

The results indicate that daily use of a bath or hot tub for 20 minutesdrains 0.5-0.7 mAh per use (or 3.5-4.9 mAh per week). Assuming that theapparatus 991 incorporates a power source similar to a cr2032 coinlithium battery (225 mAh capacity), this drain is insignificant. A dailyswim in ocean water for 20 minutes will drain ˜3.3 mAh per day (or ˜21mAh per week), which is insignificant when compared to the suggestedpower source capacity. Further, the current drain during the dryingperiod of 1 hour (for apparatus 990) is less than 1 mA per use (7 mAhper week) and does not add significant discharge compared with the powersource capacity. After removal from the liquid, apparatus 991, which hasa hydrophobic plastic barrier (similar to barrier 218 described above)ensures significantly lower power source discharge current compared toapparatus 990, which lacks a barrier. A significant amount of electricalcurrent escapes via apparatus 990 and would not be expected to reach thebody when apparatus 990 is exposed to liquid. However, apparatus 991would be expected to divert most of the electrical current to the body,if wiped.

What is claimed is:
 1. An apparatus, comprising: a rigid base having aprotrusion, the base configured to be coupled to an electronic device;and a flexible substrate having a first surface and a second surface andincluding an electrical circuit configured to electronically couple theelectronic device to an antenna, the antenna coupled directly to theflexible substrate, the flexible substrate coupled to the base such thata first portion of the second surface is in contact with the protrusion,a second portion of the second surface is non-parallel to the firstportion.
 2. The apparatus of claim 1, wherein at least a first portionof the flexible substrate is disposed within a first slot defined by thebase, at least a second portion of the flexible substrate is disposedwithin a second slot defined by the base, the first slot different thanthe second slot.
 3. The apparatus of claim 1, wherein the base defines aplurality of slots, each slot of the plurality of slots configured toreceive a portion of the flexible substrate.
 4. The apparatus of claim1, wherein: a first portion of the first surface of the flexiblesubstrate includes at least a portion of the electrical circuit, theportion of the electrical circuit configured to be in electricalcommunication with an electrical contact disposed on a first portion ofthe electronic device; and the base includes a second protrusionconfigured to engage a second portion of the electronic device when theelectronic device is coupled to the base, the second portion of theelectronic device different than the first portion of the electronicdevice.
 5. The apparatus of claim 1, further comprising: a hydrogelelectrode coupled to the second surface of the substrate, the substratefurther including a conductive region electrically coupled to theelectrical circuit and a plurality of nonconductive regions configuredto facilitate retention of the hydrogel electrode with respect to thesecond surface of the substrate.
 6. The apparatus of claim 1, whereinthe electrical circuit is configured to electronically couple theelectronic device to at least one of an electrode or a battery.
 7. Anapparatus, comprising: a flexible housing configured to be disposedabout at least a portion of a stimulator assembly, the stimulatorassembly including at least a battery, an electrode, and a stimulusgenerator, the housing including a receiving portion configured toreceive at least a portion of the stimulus generator, the receivingportion defining a first opening configured to receive a protrusion ofthe stimulus generator when the stimulus generator is received in thereceiving portion such that the stimulus generator is electricallycoupled to the battery, the receiving portion defining a second openingdifferent than the first opening, the second opening configured toreceive a protrusion of a base of the stimulator assembly such that theprotrusion can limit movement of the stimulus generator with respect tothe housing when the stimulus generator is received in the receivingportion of the housing.
 8. The apparatus of claim 7, wherein a portionof the housing is configured to form a substantially fluid-tight sealproximate to the receiving portion when at least the portion of thestimulus generator is received in the receiving portion.
 9. Theapparatus of claim 7, wherein the housing defines a recess configured toreceive a fastening member of the stimulator assembly, the fasteningmember configured to limit movement of the housing relative to thestimulator assembly when the housing is disposed about the portion ofthe stimulator assembly and the fastening member is received in therecess.
 10. The apparatus of claim 7, wherein the housing is configuredto substantially maintain the stimulus generator in electricalcommunication with an electrical pathway coupled to a substrate of thestimulator assembly when the stimulus generator is received in thereceiving portion, the electrical pathway electrically couples thestimulus generator to at least one of the electrode or the battery. 11.A method, comprising the steps of: folding a tab portion of a flexiblesubstrate such that the tab portion of the flexible substrate is incontact with a bottom side of a body portion of the flexible substrateand such that an electrical circuit formed on a top side of the flexiblesubstrate extends about an edge of the fold, the flexible substrateconfigured to be coupled to a body.
 12. The method of claim 11, furthercomprising: coupling at least a portion of the flexible substrate to arigid base.
 13. The method of claim 11, further comprising: disposing afirst portion of the flexible substrate including the electrical circuitover a protrusion of a rigid base such that the first portion of theflexible substrate is non-parallel to a second portion of the flexiblesubstrate.
 14. The method of claim 11, further comprising: weaving atleast a portion of the flexible substrate through a slot defined by arigid base.
 15. The method of claim 11, wherein the tab portion is afirst tab portion, further comprising: folding a second tab portion ofthe flexible substrate such that the second tab portion of the flexiblesubstrate is in contact with the bottom side of the body portion of theflexible substrate and such that the electrical circuit extends about anedge of the fold of the second tab portion.
 16. An apparatus,comprising: a hydrogel electrode; and a substrate including a lowersurface, a conductive region, and a plurality of discrete non-conductiveregions, the conductive region electrically coupled to an electricalcircuit of the substrate and to the hydrogel electrode, the plurality ofdiscrete non-conductive regions configured to facilitate coupling of thehydrogel electrode with the lower surface of the substrate, at least onenon-conductive region of the plurality of discrete non-conductiveregions is at least one of (1) a solder mask, (2) a cavity formed in asurface of the conductive region, or (3) formed by a coating applied toa surface of the conductive region.
 17. The apparatus of claim 16,wherein at least one non-conductive region of the plurality of discretenon-conductive regions is formed by a coating applied to the surface ofthe conductive region.
 18. The apparatus of claim 16, wherein at leastone non-conductive region of the plurality of discrete non-conductiveregions is a cavity formed in a surface of the conductive region. 19.The apparatus of claim 16, wherein at least one non-conductive region ofthe plurality of discreet non-conductive regions is a solder mask. 20.An apparatus, comprising: a hydrogel electrode; and a substrateincluding a lower surface, a conductive region, and a plurality ofdiscrete non-conductive regions, the conductive region electricallycoupled to an electrical circuit of the substrate and to the hydrogelelectrode, the plurality of discrete non-conductive regions configuredto facilitate coupling of the hydrogel electrode with the lower surfaceof the substrate, at least one non-conductive region of the plurality ofdiscrete non-conductive regions extending beyond a surface of theconductive region.